CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Vancomycin Oral Capsule +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03030248
NCT03030248Phase 2Completed
CompareCT.gov

Randomized Double Blind Controlled Trial for the Treatment of Nucleic Acid Amplification Test (NAAT)+/Toxin Enzyme Immunoassay (EIA)- Clostridium Difficile in the Hematology Oncology Population

Medical College of Wisconsin·interventional·Posted Jan 24, 2017·Updated Apr 15, 2026

In Brief

A Phase 2 clinical trial evaluating Vancomycin Oral Capsule and Placebo Oral Capsule for Clostridium Difficile Infection and 3 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection, Hematologic Diseases, Bone Marrow Transplant, Oncologic Disorders
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 24, 2017
Enrollment StartJun 1, 2018
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.4 years ago

Interventions

Vancomycin Oral Capsuledrug

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 Oral Capsuledrug

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.