Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients (NCT03030248) | Clinical Trial Compass
CompletedPhase 2
Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients
United States9 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Clostridium Difficile Bacterial Loads in the Stool
Timeframe: First sample versus last stool sample collected, up to 90 days