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More info
You can access this
clinical trial
if you have
Clostridium Difficile Infection
and you are
over 18
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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Since then, NAAT became the standard diagnostic test for over 60% of US hospitals (National Healthcare Safety Network, unpublished data).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.

Provided treatments

  • Drug: Vancomycin Oral Capsule
  • Drug: Placebo Oral Capsule
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Locations near you

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Tris trial is registered with FDA with number: NCT03030248. The sponsor of the trial is Medical College of Wisconsin and it is looking for 30 volunteers for the current phase.
Official trial 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