Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359970
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2006-08-01
Brief Title:
Azithromycin With or Without Loperamide to Treat Travelers Diarrhea
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Loperamide Plus Azithromycin More Effectively Treats Travelers Diarrhea In Mexico Than Azithromycin Alone
Status:
COMPLETED
Status Verified Date:
2015-06
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:
In a previous study azithromycin proved as efficacious as levofloxacin in the treatment of travelers diarrhea in Mexico Because the addition of loperamide to some antibiotics eg trimethoprim-sulfamethoxazole and ofloxacin has proven more efficacious than antibiotic alone in the treatment of travelers diarrhea we decided to study the addition of loperamide to azithromycin
US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin in two different doses or loperamide plus azithromycin
The duration of diarrhea was shorter 11 hours in the combination-treated group compared to the antibiotic-treated groups 34 hours The percentage of subjects continuing to pass 6 or more unformed stools in the first 24 hours was less 17 in the combination-treated group than in the antibiotic-treated groups 20
We feel loperamide should routinely be added to an antibiotic to optimize treatment of travelers diarrhea
US adults with acute diarrhea in Guadalajara Mexico were randomized to receive azithromycin in two different doses or loperamide plus azithromycin
The duration of diarrhea was shorter 11 hours in the combination-treated group compared to the antibiotic-treated groups 34 hours The percentage of subjects continuing to pass 6 or more unformed stools in the first 24 hours was less 17 in the combination-treated group than in the antibiotic-treated groups 20
We feel loperamide should routinely be added to an antibiotic to optimize treatment of travelers diarrhea
Detailed Description:
Background The combination of loperamide and trimethoprim-sulfamethoxazole or a fluoroquinolone has proven to be more efficacious than the antimicrobial agent alone in the treatment of travelers diarrhea We set out to prove loperamide plus azithromycin was more efficacious that azithromycin alone
Methods During the summers of 2002-3 176 US adults recently arrived in Guadalajara Mexico were enrolled in a prospective double-blinded randomized trial of the treatment of acute diarrhea Subjects received single doses 1000 mg or 500 mg of azithromycin or a single 500 mg dose of azithromycin plus loperamide Subjects gave a pre and post treatment stool sample for analysis and maintained daily diaries of symptoms and passage of stools
Results The MIC90 of azithromycin for all E coli and Shigella was 003 and 4 µgml with eradication rates in day 5 stools of 88 and 100 respectively The duration of diarrhea was significantly p00002 shorter following treatment with azithromycin plus loperamide 11 h than with either dose of azithromycin alone 34 h In the first 24 h the average number of unformed stools passed was 34 azithromycin-alone and 12 combination for a significant p00001 difference of 22 unformed stools This difference equated with 20 of azithromycin-treated subjects continuing to pass 6 or more unformed stools in the first 24 h post treatment compared with only 17 of combination-treated subjects
Conclusions For the treatment of travelers diarrhea in an E coli predominant region of the world a single 500 mg dose of azithromycin appeared as effective as a 1000 mg dose Loperamide plus 500 mg azithromycin was safe and more effective than either dose of azithromycin To realize the substantial clinical benefit that accrues to a subset of subjects we feel loperamide should routinely be used in combination with an antimicrobial agent to treat travelers diarrhea
Methods During the summers of 2002-3 176 US adults recently arrived in Guadalajara Mexico were enrolled in a prospective double-blinded randomized trial of the treatment of acute diarrhea Subjects received single doses 1000 mg or 500 mg of azithromycin or a single 500 mg dose of azithromycin plus loperamide Subjects gave a pre and post treatment stool sample for analysis and maintained daily diaries of symptoms and passage of stools
Results The MIC90 of azithromycin for all E coli and Shigella was 003 and 4 µgml with eradication rates in day 5 stools of 88 and 100 respectively The duration of diarrhea was significantly p00002 shorter following treatment with azithromycin plus loperamide 11 h than with either dose of azithromycin alone 34 h In the first 24 h the average number of unformed stools passed was 34 azithromycin-alone and 12 combination for a significant p00001 difference of 22 unformed stools This difference equated with 20 of azithromycin-treated subjects continuing to pass 6 or more unformed stools in the first 24 h post treatment compared with only 17 of combination-treated subjects
Conclusions For the treatment of travelers diarrhea in an E coli predominant region of the world a single 500 mg dose of azithromycin appeared as effective as a 1000 mg dose Loperamide plus 500 mg azithromycin was safe and more effective than either dose of azithromycin To realize the substantial clinical benefit that accrues to a subset of subjects we feel loperamide should routinely be used in combination with an antimicrobial agent to treat travelers diarrhea
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