Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody

September 9, 2010 updated by: Michael E. DeBakey VA Medical Center

Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-C.Difficile Toxin Antibody

The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.

Study Overview

Status

Completed

Conditions

Detailed Description

Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and mortality that may be around 2-3%. Current recommended therapy for this condition is metronidazole, given orally. Our observations suggest that about 10-20% of patients fail to respond to initial therapy with metronidazole, and 20% relapse after treatment. The reason why some persons are cured whereas others relapse is, at present, unknown. There is a suggestion in the medical literature that recurrent infection is associated with the failure to generate antibody to C. difficile toxin. It is also possible that those patients who become infected lack antibody, whereas others in the population tend to have such antibody. The investigators propose to study our patients at VAMC Houston in order to relate occurrence and/or the failure to respond to therapy or the appearance of recurrent disease to the presence of anti-toxin antibody. The investigators also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.

Study Type

Observational

Enrollment (Actual)

10

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
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA 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

  • Child
  • 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:

  • All patients at the Houston VA with documented C. difficile infection

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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., Michael E. DeBakey 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

January 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Estimate)

September 10, 2010

Last Update Submitted That Met QC Criteria

September 9, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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