Trial Outcomes & Findings for Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients (NCT NCT03030248)
NCT ID: NCT03030248
Last Updated: 2026-04-15
Results Overview
Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR). Values obtained from initial sample (pre-treatment) were compared with values from the last sample obtained for each patient.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
First sample versus last stool sample collected, up to 90 days
Results posted on
2026-04-15
Participant Flow
Participant milestones
| Measure |
Vancomycin Treated Group
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
Vancomycin Oral Capsule: We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.
|
Placebo Group
This group will be given placebo oral capsules every 6 hours for 14 days.
Placebo Oral Capsule: A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients
Baseline characteristics by cohort
| Measure |
Vancomycin Treated Group
n=5 Participants
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
Vancomycin Oral Capsule: We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.
|
Placebo Group
n=4 Participants
This group will be given placebo oral capsules every 6 hours for 14 days.
Placebo Oral Capsule: A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=193 Participants
|
4 participants
n=193 Participants
|
9 participants
n=386 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: First sample versus last stool sample collected, up to 90 daysPopulation: Only 4 participants in the vancomycin group were analyzed given that one failed to give stool samples. In the placebo group all first samples were available for all 4 participants; however, only 2 participants provided a follow up sample ("last sample").
Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR). Values obtained from initial sample (pre-treatment) were compared with values from the last sample obtained for each patient.
Outcome measures
| Measure |
Vancomycin Treated Group
n=4 Participants
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
Vancomycin Oral Capsule: We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.
|
Placebo Group
n=4 Participants
This group will be given placebo oral capsules every 6 hours for 14 days.
Placebo Oral Capsule: A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.
|
|---|---|---|
|
Changes in Clostridium Difficile Bacterial Loads in the Stool
Mean - first sample
|
62102500.00 CFUs
Standard Deviation 79994345.79
|
40000000.00 CFUs
Standard Deviation 80000000.00
|
|
Changes in Clostridium Difficile Bacterial Loads in the Stool
Mean - last sample
|
7752750.00 CFUs
Standard Deviation 15498167.53
|
185000.00 CFUs
Standard Deviation 261629.51
|
Adverse Events
Vancomycin Treated Group
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vancomycin Treated Group
n=5 participants at risk
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
Vancomycin Oral Capsule: We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.
|
Placebo Group
n=4 participants at risk
This group will be given placebo oral capsules every 6 hours for 14 days.
Placebo Oral Capsule: A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.
|
|---|---|---|
|
Infections and infestations
sepsis
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/5 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
Other adverse events
| Measure |
Vancomycin Treated Group
n=5 participants at risk
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
Vancomycin Oral Capsule: We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.
|
Placebo Group
n=4 participants at risk
This group will be given placebo oral capsules every 6 hours for 14 days.
Placebo Oral Capsule: A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
40.0%
2/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
50.0%
2/4 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Hepatobiliary disorders
Changes in hepatic function
|
60.0%
3/5 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
50.0%
2/4 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
50.0%
2/4 • Number of events 5 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Renal and urinary disorders
Creatinine increase
|
20.0%
1/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
75.0%
3/4 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
General disorders
Edema
|
40.0%
2/5 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
50.0%
2/4 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Epistaxis
|
20.0%
1/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Infections and infestations
Fever
|
40.0%
2/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
General disorders
Weakness
|
40.0%
2/5 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
General disorders
Headache
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Endocrine disorders
Hyperglycemia
|
60.0%
3/5 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/5 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Number of events 5 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
60.0%
3/5 • Number of events 6 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
75.0%
3/4 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
20.0%
1/5 • Number of events 2 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 3 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Blood and lymphatic system disorders
White count changes
|
20.0%
1/5 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 10 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
General disorders
Weight loss
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
25.0%
1/4 • Number of events 4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Cardiac disorders
Platelet count abnormalities
|
20.0%
1/5 • Number of events 1 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
50.0%
2/4 • Number of events 8 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
|
Cardiac disorders
Hypertension
|
60.0%
3/5 • Number of events 7 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
0.00%
0/4 • The time frame spanned from enrollment to off treatment (up to 90 days) or withdrawal from study, whatever happened first.
Our definition mirrored clinicaltrials.gov
|
Additional Information
L. Silvia Munoz-Price, MD, PhD Enterprise Epidemiologist Professor of Medicine
Medical College of Wisconsin
Phone: 414-955-0483
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place