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Vancomycin for the Treatment of NAAT(+)/Toxin(-) C. Difficile

NCT ID: NCT03827447

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2021-06-30

Brief Summary

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This study proposes to:

1. Characterize the impact of oral vancomycin on C. difficile loads after end of treatment compared to a placebo group.
2. Determine the effect of oral vancomycin on structural and functional microbiome changes after end of treatment compared to a placebo group.
3. Characterize the impact of oral vancomycin against a placebo group on the daily frequency of loose stools by the end of treatment.

Detailed Description

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Clostridium difficile infection (CDI) is considered the most frequent healthcare associated infection in the US, causing almost half a million cases per year with an estimated annual cost of 4.8 billion dollars. Despite the existence of a few treatment options against CDI, yearly attributable deaths are estimated at 29,300 in the US. From April 2014 to April 2016, Froedtert Health reported 899 CDIs. Over half of these events are NAAT (Nucleic Acid Amplification Test)(+)/EIA (Enzyme immunoassay)(-) events. To test for CDI, NAAT followed by EIA is used in a Multistep algorithmic testing in which a sensitive nucleic acid amplification test (NAAT) is followed by a specific toxin A and toxin B enzyme immunoassay (EIA) and are among the most accurate methods for Clostridium difficile infection (CDI) diagnosis. There is currently uncertainty on how to treat these CDI events.

The primary outcome of this randomized double blind controlled intervention trial will be changes in C. difficile (Clostridium difficile) loads between day 1 and day 14 and changes in C. difficile load between day 14 and day 28. Thirty patients with documented C. difficile will be randomized to either 14 days of vancomycin or placebo capsules. Block randomization will be used to assign patients to the treatment or placebo arms. Randomized assignments will be placed in sealed envelopes which will only be handled by the research pharmacist. Study related stool collections will be obtained on days 1, 7, 14, 21, and 28 (+/- 2days) \[Day 1=first day study drug was administered\]. Patients will be followed for 90 days starting on day 1. Patients unable to complete at least 7 days of study treatment will be removed from analysis and replaced.

Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be divided into 2 groups, one receiving oral vancomycin and the other placebo.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
After enrollment, patients will be randomized to treatment with vancomycin 125 mg capsules by mouth every 6 hours for 14 days or to placebo with identical looking capsules for the same length of treatment. Block randomization will be used to assign patients to the treatment or placebo arms. Randomized assignments will be placed in sealed envelopes which will only be handled by the research pharmacist. Clinical providers, research team, and patients will remain blinded to allocation

Study Groups

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Drug: Vancomycin Group

Subjects will receive oral vancomycin capsules by mouth, 125 mg every 6 hours for 14 days.

Group Type ACTIVE_COMPARATOR

Vancomycin Oral Capsule

Intervention Type DRUG

125 mg capsules every 6 hours for 14 days.

Drug: Placebo Group

Subjects will receive a placebo oral capsule by mouth every 6 hours for 14 days. The placebo oral capsule is manufactured by Study Site's pharmacy to be identical in size, shape, color, appearance and taste as the drug comparator

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

Gelatin pill manufactured to mimic 125 mg Vancomycin oral capsule

Interventions

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Vancomycin Oral Capsule

125 mg capsules every 6 hours for 14 days.

Intervention Type DRUG

Placebo Oral Capsule

Gelatin pill manufactured to mimic 125 mg Vancomycin oral capsule

Intervention Type DRUG

Other Intervention Names

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Vancocin

Eligibility Criteria

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Inclusion Criteria

* Must be at least 18 years of age at time of consent.
* Presence of loose stools triggering clinical C. difficile NAAT/toxin EIA testing.
* Having both C. difficile NAAT (+) and C. difficile toxin EIA (-).
* Admitted outside the hematology-oncology unit.
* Must be willing to keep a study supplied drug diary

Exclusion Criteria

* Presence of sepsis. Sepsis will be defined as a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions.
* Inability to take oral medications.
* Unwillingness or inability to provide written informed consent.
* Has a documented allergy to vancomycin.
* Has a documented life expectancy shorter than treatment course (14 days).
* Unwilling or unable to collect stool samples in the outpatient setting after discharge.
* Diagnosis of C. difficile colitis \[NAAT(+) and toxin EIA(+)\] in the preceding 3 months from enrollment.
* Received oral vancomycin during their current hospitalization, excluding empiric treatment given while pending C. difficile NAAT/toxin EIA results. Intravenous vancomycin is not an exclusion criterion.
* Women known to be pregnant or lactating during the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Silvia Munoz-Price

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silvia Munoz-Price, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00033844

Identifier Type: -

Identifier Source: org_study_id