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

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
VA Medical Center, Houston
ClinicalTrials.gov Identifier:
NCT00304408
First received: March 16, 2006
Last updated: September 9, 2010
Last verified: September 2010
  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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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. Houston VA Medical Center
  More Information

No publications provided

Responsible Party: Daniel Musher, MD, VAHouston
ClinicalTrials.gov Identifier: NCT00304408     History of Changes
Other Study ID Numbers: H-16383
Study First Received: March 16, 2006
Last Updated: September 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
Clostridium difficile

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

ClinicalTrials.gov processed this record on October 23, 2014