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Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody
This study is currently recruiting participants.
Verified by VA Medical Center, Houston, September 2005
First Received: March 16, 2006   No Changes Posted
Sponsors and Collaborators: VA Medical Center, Houston
Baylor College of Medicine
Information provided by: VA Medical Center, Houston
ClinicalTrials.gov Identifier: NCT00304408
  Purpose

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.


Condition Phase
Clostridium Enterocolitis
Pseudomembranous Colitis
Antibiotic-Associated Colitis
Phase IV

Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-C.Difficile Toxin Antibody

Further study details as provided by VA Medical Center, Houston:

Estimated Enrollment: 200
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. We 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. We also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304408

Contacts
Contact: Daniel M Musher, M.D. 713-794-7384 dmusher@bcm.tmc.edu
Contact: Nancy L Logan, M.A. 713-794-7384 njarrar@bcm.tmc.edu

Locations
United States, Texas
Michael E. Debakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel M Musher, M.D.            
Sub-Investigator: Nancy L Logan, M.A.            
Sponsors and Collaborators
VA Medical Center, Houston
Baylor College of Medicine
Investigators
Principal Investigator: Daniel M Musher, M.D. Houston VA Medical Center
  More Information

No publications provided

Study ID Numbers: H-16383
Study First Received: March 16, 2006
Last Updated: March 16, 2006
ClinicalTrials.gov Identifier: NCT00304408     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
Clostridium difficile

Study placed in the following topic categories:
Bacterial Infections
Gastrointestinal Diseases
Colonic Diseases
Enterocolitis, Pseudomembranous
Clostridium Difficile
Intestinal Diseases
Enterocolitis
Gram-Positive Bacterial Infections
Antibodies
Digestive System Diseases
Gastroenteritis
Clostridium Infections
Colitis
Immunoglobulins

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Enterocolitis, Pseudomembranous
Clostridium Infections
Intestinal Diseases
Gastroenteritis
Enterocolitis
Colitis

ClinicalTrials.gov processed this record on August 24, 2009