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

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ClinicalTrials.gov Identifier: NCT00304408
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : September 10, 2010
Baylor College of Medicine
Information provided by:
VA Medical Center, Houston

Brief Summary:
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 or disease Phase
Clostridium Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis Phase 4

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
Actual Enrollment : 10 participants
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
Study Start Date : January 2005
Primary Completion Date : January 2008
Study Completion Date : January 2008

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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.

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Principal Investigator: Daniel M Musher, M.D. VA Medical Center, Houston

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

Keywords provided by VA Medical Center, Houston:
Clostridium difficile

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