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Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy

NCT00591357 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-05-03

No results posted yet for this study

Summary

To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C. diff positive and negative patients will be included.

Conditions

  • Antibiotic-Associated Diarrhea
  • Clostridium Difficile

Interventions

DRUG

loperamide

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

DRUG

placebo

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    lead FED

Principal Investigators

  • Daniel M Musher, MD · Michael E. DeBakey VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2013-12-31

Countries

  • United States

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 NCT00591357 on ClinicalTrials.gov