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Completed

NCT Number: NCT03030248

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

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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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Bone Marrow Transplant Clostridium Infections Gram-Positive Bacterial Infections Hematologic Diseases Hemic and Lymphatic Diseases Infections Oncologic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin Oral Capsule

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.

Other names: Vancocin hydrochloride Oral Capsule

Placebo oral capsule

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.

Primary outcomes

  1. Changes in Clostridium Difficile Bacterial Loads in the Stool

    Time frame: First sample versus last stool sample collected, up to 90 days

    Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR). Values obtained from initial sample (pre-treatment) were compared with values from the last sample obtained for each patient.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2017
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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