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Optimal Treatment for Recurrent Clostridium Difficile

NCT02667418 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2025-12-15

Study results available
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Summary

The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.

Conditions

Interventions

DRUG

Fidaxomicin

200 mg PO twice daily for 10 days

DRUG

Vancomycin with Taper/Pulse

125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days

DRUG

Vancomycin

125 mg PO for times daily for 10 days

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Stuart B. Johnson, MD BA · Edward Hines Jr. VA Hospital, Hines, IL

  • Dale N Gerding, MD · Edward Hines Jr. VA Hospital, Hines, IL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2024-08-07
Completion
2024-08-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

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 NCT02667418 on ClinicalTrials.gov