Trial Outcomes & Findings for Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection (NCT NCT03462459)
NCT ID: NCT03462459
Last Updated: 2025-05-25
Results Overview
Determine whether CDI recurrence is decreased in patients taking oral vancomycin as prophylactic therapy in addition to standard-of-care antibiotics that patients are taking for non-CDI reasons.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Vancomycin
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
42
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
| Measure |
Vancomycin
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Unable to complete doses of study drug/placebo
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Unable to obtain stool samples at visit
|
0
|
1
|
Baseline Characteristics
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
Vancomycin
n=37 Participants
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 Participants
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.89 years
STANDARD_DEVIATION 15 • n=99 Participants
|
58.40 years
STANDARD_DEVIATION 13 • n=107 Participants
|
58.65 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksDetermine whether CDI recurrence is decreased in patients taking oral vancomycin as prophylactic therapy in addition to standard-of-care antibiotics that patients are taking for non-CDI reasons.
Outcome measures
| Measure |
Vancomycin
n=37 Participants
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 Participants
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Recurrent Clostridium Difficile Infection (CDI)
|
17 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 8 weeksStudy how the gut microbiome is altered in patients receiving vancomycin treatment compared to placebo.
Outcome measures
| Measure |
Vancomycin
n=39 stool samples
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 stool samples
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Gut Microbiome Composition
|
NA stool samples
Data could not be reported due to low sample volumes for genomic sequencing. Genomic sequencing could not be done and comparisons between vancomycin and placebo also cannot be done.
|
NA stool samples
Data could not be reported due to low sample volumes for genomic sequencing. Genomic sequencing could not be done and comparisons between vancomycin and placebo also cannot be done.
|
SECONDARY outcome
Timeframe: 8 weeksLow-dose exposure to vancomycin and VRE infection has not been studied. We will examine the incidence of VRE colonization in stool samples of all patients and determine whether oral vancomycin increases the VRE colonization rate, which has a negative impact on the overall health of patients being treated with vancomycin for C. difficile infection.
Outcome measures
| Measure |
Vancomycin
n=37 Participants
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 Participants
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Vancomycin-resistant Enterococcus (VRE) Colonization in Stool Samples of Patients Receiving Vancomycin vs. Patients Receiving Placebo
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 weeksStool samples will be tested at baseline, at the last dose date of vancomycin or placebo, at approximately 8 weeks following the last dose of vancomycin or placebo, and as indicated for diarrhea symptoms. Samples will be collected and tested for the presence of Clostridium difficile.
Outcome measures
| Measure |
Vancomycin
n=39 stool samples
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 stool samples
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Determine Whether Clostridium Difficile Positivity on Any Stool Sample is a Predictor of CDI Recurrence.
|
NA stool samples
Data cannot be reported due to low available sample volumes for culture testing.
|
NA stool samples
Data cannot be reported due to low available sample volumes for culture testing.
|
Adverse Events
Vancomycin
Serious events: 9 serious events
Other events: 37 other events
Deaths: 1 deaths
Placebo
Serious events: 10 serious events
Other events: 42 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Vancomycin
n=37 participants at risk
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 participants at risk
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Infections and infestations
Pneumonia with associated shock
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Bacteremia/Sepsis
|
0.00%
0/37 • 8 weeks
|
4.8%
2/42 • Number of events 2 • 8 weeks
|
|
Gastrointestinal disorders
Elevated liver function tests due to transplant
|
2.7%
1/37 • Number of events 3 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Gastrointestinal disorders
Recurrent C difficile Infection (rCDI)
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Blood and lymphatic system disorders
Sickle Cell Pain Crisis
|
2.7%
1/37 • Number of events 4 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Cellulitis
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Thrombophlebitis
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Cardiac disorders
Congestive Heart Failure Exacerbation
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Surgical and medical procedures
Whipple Procedure
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
General disorders
General weakness/malaise
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Toe Infection
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Infections and infestations
Osteomyelitis
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Psychiatric disorders
Altered Mental Status
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Traumatic fall with sequelae
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Vascular disorders
Carotid endarctectomy with stents
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Surgical and medical procedures
Peripheral autologous stem cell transplant
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Surgical and medical procedures
Sigmoid resection surgery
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Reproductive system and breast disorders
Vaginal Polyp
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Cardiac disorders
Heart Failure
|
2.7%
1/37 • Number of events 1 • 8 weeks
|
0.00%
0/42 • 8 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/37 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
Other adverse events
| Measure |
Vancomycin
n=37 participants at risk
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin: Vancomycin capsule, 125 mg
|
Placebo
n=42 participants at risk
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Placebo: Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
16.2%
6/37 • Number of events 8 • 8 weeks
|
23.8%
10/42 • Number of events 12 • 8 weeks
|
|
General disorders
Fever/Flu-Like Symptoms
|
8.1%
3/37 • Number of events 3 • 8 weeks
|
4.8%
2/42 • Number of events 2 • 8 weeks
|
|
Infections and infestations
UTI
|
8.1%
3/37 • Number of events 4 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Infections
|
10.8%
4/37 • Number of events 5 • 8 weeks
|
7.1%
3/42 • Number of events 3 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain and swelling
|
10.8%
4/37 • Number of events 4 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal Pain/Discomfort
|
24.3%
9/37 • Number of events 12 • 8 weeks
|
21.4%
9/42 • Number of events 9 • 8 weeks
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
24.3%
9/37 • Number of events 10 • 8 weeks
|
11.9%
5/42 • Number of events 5 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.8%
4/37 • Number of events 6 • 8 weeks
|
19.0%
8/42 • Number of events 9 • 8 weeks
|
|
Gastrointestinal disorders
Bloating/flatulence
|
10.8%
4/37 • Number of events 4 • 8 weeks
|
16.7%
7/42 • Number of events 7 • 8 weeks
|
|
Gastrointestinal disorders
Bloody stool/loose stool
|
10.8%
4/37 • Number of events 4 • 8 weeks
|
2.4%
1/42 • Number of events 1 • 8 weeks
|
Additional Information
Nasia Safdar, Professor
University of Wisconsin-Madison
Phone: 608-265-1545
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place