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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304408
First Posted: March 17, 2006
Last Update Posted: September 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baylor College of Medicine
Information provided by:
VA Medical Center, Houston
  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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:

Enrollment: 10
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients positive for C. difficile.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304408


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

Responsible Party: Daniel Musher, MD, VAHouston
ClinicalTrials.gov Identifier: NCT00304408     History of Changes
Other Study ID Numbers: H-16383
First Submitted: March 16, 2006
First Posted: March 17, 2006
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by VA Medical Center, Houston:
Clostridium difficile

Additional relevant MeSH terms:
Colitis
Enterocolitis
Enterocolitis, Pseudomembranous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs