Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098384
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
2004-12-07
Brief Title:
Rifaximin Versus Placebo in the Prevention of Travelers Diarrhea
Sponsor:
DuPont Hurbert L MD
Organization:
DuPont Hurbert L MD
Study Overview
Official Title:
A Randomized Double-Blind Single Center Comparative Dose Ranging Study of Rifaximin Vs Placebo in the Prevention of Travelers Diarrhea Due to Enteropathogenic Bacteria
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers diarrhea among US college students in Mexico for five weeks
Detailed Description:
This is an investigator-initiated proposal wherein 220 male and female subjects 17 years of age from industrialized regions were randomized to receive a poorly absorbed antibiotic rifaximin in one of three doses at mealtime when they are exposed to diarrhea-causing bacteria 200 mg once a day 200 mg twice a day or 200 mg three times a day versus a placebo starting on arrival within the first 72 hours to Mexico and continuing for two weeks with diaries of symptoms recorded for three weeks Adverse events in the subjects were followed for five weeks If mild diarrhea 1 or 2 unformed stools24 hours plus an enteric symptom or diarrheal illness 2 unformed stools24 hours plus an enteric symptom developed subjects provided a stool sample to determine cause of illness Forty subjects provided stool samples after 7 days and 14 days treatment to see if their intestinal bacterial flora had developed resistance to rifaximin and to see the level of drug achieved Stool samples from these forty subjects were studied for enteric pathogens to look for asymptomatic infection during the period of prophylaxis The stool samples collected were initially processed in our enteric laboratories in Guadalajara Mexico Specialized tests such as studies of toxigenicity for enterotoxigenic E coli and enteroadherence for enteroaggregative E coli were done in Houston
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