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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-) patients may be particularly important in transplant recipients. The usual treatment prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this drug has excellent activity against C. difficile and commonly suppresses its growth to non-detection, it does not eradicate carriage and its use results in marked and prolonged disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal microbiota disruption at the time of HSCT engraftment has been demonstrated to be an independent predictor (controlling for other markers of underlying disease) of overall and transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile patients might have significant negative repercussions without a clear clinical benefit.

Conditions

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Clostridium Difficile Infection Hematologic Diseases Bone Marrow Transplant Oncologic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be divided into two groups, one receiving oral vancomycin capsules, the other receiving oral placebo capsules.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Vancomycin treated group

This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.

Group Type ACTIVE_COMPARATOR

Vancomycin Oral Capsule

Intervention Type DRUG

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 group

This group will be given placebo oral capsules every 6 hours for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Vancocin hydrochloride Oral Capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No