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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03030248
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : September 10, 2020
Information provided by (Responsible Party):
Silvia Munoz-Price, Medical College of Wisconsin

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Hematologic Diseases Bone Marrow Transplant Oncologic Disorders Drug: Vancomycin Oral Capsule Drug: Placebo Oral Capsule Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
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 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.
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03030248

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United States, Wisconsin
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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Principal Investigator: Silvia Munoz-Price, M.D., Ph.D. Medical College of Wisconsin
Publications of Results:
Other Publications:
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Responsible Party: Silvia Munoz-Price, Professor, Medical College of Wisconsin Identifier: NCT03030248    
Other Study ID Numbers: PRO00028749
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data to be shared would consist of age categories, genders, treatment groups, Clostridium difficile status, microbiome profile and metabolic profile. The data will be anonymized to prevent the identification of individual patients from the data provided. The data would be made available through contacting the principal investigator directly.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Silvia Munoz-Price, Medical College of Wisconsin:
bone marrow transplantation
Clostridium difficile
Additional relevant MeSH terms:
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Clostridium Infections
Hematologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents