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TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment

NCT03388268 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-07-26

Study results available
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Summary

The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.

Currently, healthcare facilities use a wide variety of tests and strategies for identifying patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI; while this treatment is standard of care at many facilities, the risk and benefits of treating these patients for CDI is unknown.

We propose to perform a double blinded, randomized controlled non-inferiority trial of antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and benefits of CDI treatment in this population.

Conditions

  • Clostridium Difficile Infection
  • Diarrhea

Interventions

DRUG

Oral Vancomycin

Oral vancomycin 125mg 4 times per day

DRUG

Placebo

Sugar liquid manufactured to mimic oral vancomycin 125mg

DEVICE

Toxin enzyme immunoassay

EIA assay: Wampole/Tech Lab Tox A/B II

DEVICE

Nuceleic acid amplification test

NAAT: Xpert C. difficile, Cepheid

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Erik Dubberke, MD, MSPH · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388268 on ClinicalTrials.gov