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Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00304408
Study type Observational
Source VA Medical Center, Houston
Contact
Status Completed
Phase Phase 4
Start date January 2005
Completion date January 2008

See also
  Status Clinical Trial Phase
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Completed NCT00304876 - Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea N/A
Completed NCT03427229 - Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection Phase 2
Completed NCT00106509 - A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea Phase 3
Completed NCT00304369 - Response of Clostridium Difficile Infection to Metronidazole Therapy N/A
Completed NCT00304889 - Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis Phase 3
Completed NCT00304356 - Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection Phase 3
Completed NCT00182429 - Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment Phase 3
Withdrawn NCT00304863 - Addition of Lactobacillus to Metronidazole in Treatment of CDAD Phase 4