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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 (NCT03030248)

The Jackson Laboratory for Genomic Medicine
There is good evidence that randomizing C. difficile NAAT(+), toxin(-) patients to non-treatment represents an ethically tolerable risk-benefit, even in cancer patients and hematopoetic stem cell transplant (HSCT) recipients. Actually, detection of free toxin in the stool was the standard of care for the diagnosis of C. difficile infection (CDI) from 1983 through 2010. Since then, NAAT became the standard diagnostic test for over 60% of US hospitals (National Healthcare Safety Network, unpublished data). However, there is growing evidence that symptomatic patients who are NAAT(+), toxin(-) have outcomes similar to patients who are NAAT(-), toxin(-); some of these outcomes include 30-day mortality, ICU admission, and hospital readmission triggered by C. difficile. Furthermore, the United Kingdom has successfully used a similar two step diagnostic algorithm with a confirmatory toxin EIA since 2012. 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.
  • 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.
    • Vancocin hydrochloride Oral Capsule
  • 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.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital
    • Having had a bone marrow transplantation (stem cell transplant) within the past 24 months
    • Positive C. difficile surveillance test (NAAT) upon unit admission
    • 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 fever within 24 hours prior to the onset of diarrhea during index admission
    • 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
    • Absolute neutrophil count <500
    31 January, 2018
    27 November, 2017
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