Trial Outcomes & Findings for Screening to Prophylax Against Clostridium Difficile Infection - (NCT NCT02996487)

Last Updated: 2024-08-13

Results Overview

Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, polymerase chain reaction (PCR) testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin enzyme immunoassay (EIA) test, and clinical symptoms compatible with CDI. This outcome is only applicable to the two randomized arms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1294 participants

Primary outcome timeframe

12 weeks after treatment

Results posted on

2024-08-13

Participant Flow

Participants were recruited based on initiation of high-risk antibiotic treatment for a minimum expedited duration of three days, between December 15, 2016 and June 30, 2023. The first participant was enrolled on December 19, 2016 and the last participant was enrolled June 28, 2023.

Of 1294 participants consented, 728 provided stool samples. 81 met inclusion criteria of culture of stool sample verifying presence of toxigenic C. difficile, and of these 81, 27 consented to randomization to treatment with vancomycin or placebo. These 27 participants are listed in the randomized participant flow below (placebo group or vancomycin group). 647 participants who screened negative and who were not randomized were available for analysis for secondary outcome 5.

Participant milestones

Participant milestones
Measure	Placebo Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin	Screened Negative for C. Difficile Colonization Patients who screened negative at enrollment for the presence of C. difficile were not eligible for the randomized portion of the trial, but were available analysis of secondary outcome 5.
Overall Study STARTED	14	13	647
Overall Study COMPLETED	11	8	647
Overall Study NOT COMPLETED	3	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
Overall Study Lost to Follow-up	1	1
Overall Study Death	0	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=14 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=13 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin	Screened Negative for C. Difficile Colonization n=647 Participants Patients who screened negative at enrollment for the presence of C. difficile were not eligible for the randomized portion of the trial, but were available analysis of secondary outcome 5.	Total n=674 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 15.3 • n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	68.6 years STANDARD_DEVIATION 15.5 • n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	68.44 years STANDARD_DEVIATION 17.57 • n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Sex: Female, Male Female	8 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	6 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	14 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Sex: Female, Male Male	6 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	7 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	13 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	0 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	13 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	25 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	2 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	0 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) Asian	0 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	0 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	0 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	1 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	1 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) White	13 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	12 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	25 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) More than one race	0 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	0 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	0 Participants n=13 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.	—	1 Participants n=27 Participants • 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment.
Region of Enrollment United States	14 participants n=14 Participants	13 participants n=13 Participants	647 participants n=647 Participants	27 participants n=674 Participants

PRIMARY outcome

Timeframe: 12 weeks after treatment

Population: Data not available for 3 patients lost to follow-up/withdrawn in placebo arm and 4 patients lost to follow-up/withdrawn and 1 death in vancomycin arm.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=8 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks after treatment

Population: Data not available for 3 patients withdrawn/lost to follow-up in placebo arm and 4 patients withdrawn/lost to follow-up and 1 death in vancomycin arm.

Number of randomized participants with mild, moderate, severe or fulminant disease after treatment. This outcome is only applicable to the two randomized arms.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=8 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. mild	0 Participants	0 Participants
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. moderate	0 Participants	0 Participants
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. severe	0 Participants	0 Participants
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. fulminant	0 Participants	0 Participants
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. no disease	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 12 weeks after treatment

Population: Data not available for 3 patients lost to follow-up/withdrawn in placebo arm and 4 patients lost to follow-up/withdrawn and 1 death in vancomycin arm.

Number of participants who developed C difficile infection after treatment. This outcome is only applicable to the two randomized arms.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=8 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks after treatment

Population: Data not available for 3 patients withdrawn/lost to follow-up in the placebo arm, and 4 patients withdrawn/lost to follow-up plus one death in the vancomycin arm. One patient in the placebo arm did not give a stool sample.

Number of participants who remained colonized with C. difficile after treatment. This outcome is only applicable to the two randomized arms.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=8 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 weeks after antibiotics

Population: Patients were originally screened for C. difficile colonization prior to randomization. This population represents the 647 participants who initially screened negative for C. difficile colonization and were not placed into the randomized portion of the study, but were assessed at 12 weeks for C. difficile infection. This outcome is not applicable to the colonized, randomized participants.

Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.

Outcome measures

Outcome measures
Measure	Placebo n=647 Participants Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.	4 Participants	—

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Vancomycin

Serious events: 4 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=14 participants at risk Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=13 participants at risk Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
Respiratory, thoracic and mediastinal disorders Acute hypoxic respiratory failure	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Respiratory, thoracic and mediastinal disorders Acute hypoxemic respiratory failure	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease exacerbation	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Cardiac disorders Congestive heart failure	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Respiratory, thoracic and mediastinal disorders Shortness of breath	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Metabolism and nutrition disorders Hyponatremia (present at baseline)	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Gastrointestinal disorders Gastrointestinal bleed	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Gastrointestinal disorders Bloody diarrhea	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Blood and lymphatic system disorders Febrile neutropenia	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.

Other adverse events

Additional Information

Maureen Cooney

Beaumont Hospitals

Phone: 248 551-0099

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=14 participants at risk Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Placebo	Vancomycin n=13 participants at risk Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin
Gastrointestinal disorders Abdominal pain due to constipation	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Injury, poisoning and procedural complications Bruise, left breast	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Injury, poisoning and procedural complications Fall, related to previous issue with right knee	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Reproductive system and breast disorders Hemorrhagic ovarian cyst	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Gastrointestinal disorders Left lower quadrant tenderness	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Injury, poisoning and procedural complications Fall, with participant hitting head while anticoagulated	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Infections and infestations Urinary tract infection	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Gastrointestinal disorders Constipation	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Vascular disorders Phlebitis/cellulitis	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Infections and infestations Purulent drainage of left knee incision	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
Infections and infestations Infected tooth, required extraction and antibiotic prescription	0.00% 0/14 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	7.7% 1/13 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
General disorders Chills	7.1% 1/14 • Number of events 1 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.	0.00% 0/13 • 12 weeks following completion of antibiotic treatment (an average of 13 weeks total) Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls. Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.