Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients
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|ClinicalTrials.gov Identifier: NCT03030248|
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : September 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Hematologic Diseases Bone Marrow Transplant Oncologic Disorders||Drug: Vancomycin Oral Capsule Drug: Placebo Oral Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be divided into two groups, one receiving oral vancomycin capsules, the other receiving oral placebo capsules.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The allocation status of patients within this study will be held in sealed envelopes by the unblinded research pharmacist on the team. Neither the main care provider, study physicians, or the patient will know of their group, until either the end of the study (after data analysis). We will also have a blinded pharmacist.|
|Official Title:||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|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||June 30, 2020|
|Actual Study Completion Date :||June 30, 2020|
Active Comparator: Vancomycin treated group
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
Drug: Vancomycin Oral Capsule
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.
Other Name: Vancocin hydrochloride Oral Capsule
Placebo Comparator: Placebo group
This group will be given placebo oral capsules every 6 hours for 14 days.
Drug: Placebo Oral Capsule
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.
- Changes in Clostridium difficile bacterial loads in the stool [ Time Frame: Pre-treatment, 1, 7, 14, 21, 28, and 90 days past the beginning of treatment ]Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030248
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Silvia Munoz-Price, M.D., Ph.D.||Medical College of Wisconsin|