Treatment of Clostridium Difficile in Colonized Patients in the Hematology Oncology Population
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|ClinicalTrials.gov Identifier: NCT03030248|
Recruitment Status : Not yet recruiting
First Posted : January 24, 2017
Last Update Posted : November 30, 2017
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Since then, NAAT became the standard diagnostic test for over 60% of US hospitals (National Healthcare Safety Network, unpublished data).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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: Vancomycin Oral Capsule Drug: Placebo Oral Capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 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 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).|
|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|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||May 31, 2019|
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
|Contact: Silvia Munoz-Price, M.D., Ph.D.||(414) firstname.lastname@example.org|
|Principal Investigator:||Silvia Munoz-Price, M.D., Ph.D.||Medical College of Wisconsin|