Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm).

Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborator: The Jackson Laboratory for Genomic Medicine
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital

• New onset of diarrhea during hospitalization

• C. difficile clinical testing showing NAAT positive EIA negative results

Exclusion Criteria:

• Being unable to consent for self

• Inability to take enteral medications

• Unwillingness to enroll in study

• Patient has a documented allergy to vancomycin

• Patient has a documented life expectancy shorter than treatment course (14 days)

• Patient is unwilling or unable to provide stool samples in the outpatient setting after discharge

• Diagnosis of C. difficile colitis [NAAT (+) and toxin EIA (+) within 3 months of enrollment).

• New onset of abdominal distention within 24 hours prior to the onset of diarrhea during index admission

• Presence of toxic megacolon

• Presence of clinical sepsis. Sepsis will be defined as a Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions

• Pregnancy or lactating