Vancomycin for the Treatment of NAAT(+)/Toxin(-) C. Difficile

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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 structural and functional microbiome changes after end of treatment compared to a placebo group.

3. Characterize the impact of oral vancomycin against a placebo group on the daily frequency of loose stools by the end of treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.