Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304408
Status:
COMPLETED
Last Update Posted:
2010-09-10
First Post:
2006-03-16
Brief Title:
Association Between Response to Treatment of C Diff Colitis and Anti-CDiff Toxin Antibody
Sponsor:
Michael E DeBakey VA Medical Center
Organization:
Michael E DeBakey VA Medical Center
Study Overview
Official Title:
Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-CDifficile Toxin Antibody
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is three fold 1To 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 2To collect stool samples for test of C difficile toxin at similar time intervals 3To assay random serum samples from the VA lab in order to determine the rate of antibody to C difficile toxin in our patient population
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None