Clinical Trial on Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

Clostridium difficile associated colitis is an increasing problem in hospitals throughout the developed world; the number of cases has increased, and the failure to respond to conventional therapy has become far more common. The investigators have recently documented in the medical literature (Clin Infect Dis, June, 2005; Lancet Infect Dis, August, 2005). Possible reasons for failure of treatment include persistence of C. difficile and/or imbalance of other bacterial flora in the colon. The bacteriology of fecal flora in C. difficile associated diarrhea has not been studied.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21205
    - Johns Hopkins Medical Research Institute
- Texas
  - Houston, Texas, United States, 77030
    - Michael E. DeBakey Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients positive for C. difficile

Description

Inclusion Criteria:

Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin
Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin
Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy
Hospitalized patients who have received >2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael E. DeBakey VA Medical Center

Collaborators

Baylor College of Medicine

Investigators

Principal Investigator: Daniel M Musher, M.D., Baylor College of Medicine, Houston VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria