Status:
COMPLETED
Vancomycin for the Treatment of NAAT(+)/Toxin(-) C. Difficile
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study proposes to: 1. Characterize the impact of oral vancomycin on C. difficile loads after end of treatment compared to a placebo group. 2. Determine the effect of oral vancomycin on structura...
Detailed Description
Clostridium difficile infection (CDI) is considered the most frequent healthcare associated infection in the US, causing almost half a million cases per year with an estimated annual cost of 4.8 billi...
Eligibility Criteria
Inclusion
- Must be at least 18 years of age at time of consent.
- Presence of loose stools triggering clinical C. difficile NAAT/toxin EIA testing.
- Having both C. difficile NAAT (+) and C. difficile toxin EIA (-).
- Admitted outside the hematology-oncology unit.
- Must be willing to keep a study supplied drug diary
Exclusion
- Presence of sepsis. Sepsis will be defined as a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions.
- Inability to take oral medications.
- Unwillingness or inability to provide written informed consent.
- Has a documented allergy to vancomycin.
- Has a documented life expectancy shorter than treatment course (14 days).
- Unwilling or unable to collect stool samples in the outpatient setting after discharge.
- Diagnosis of C. difficile colitis \[NAAT(+) and toxin EIA(+)\] in the preceding 3 months from enrollment.
- Received oral vancomycin during their current hospitalization, excluding empiric treatment given while pending C. difficile NAAT/toxin EIA results. Intravenous vancomycin is not an exclusion criterion.
- Women known to be pregnant or lactating during the study.
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03827447
Start Date
July 17 2019
End Date
June 30 2021
Last Update
October 20 2021
Active Locations (1)
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1
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226