Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299208
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2006-03-03
Brief Title:
Azithromycin Combination Therapy for Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Open Label Randomized Study of Azithromycin Combination Therapy for the Treatment of Acute Uncomplicated Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2010-03
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 goal of this study is to develop a safe well tolerated and highly efficacious azithromycin combination treatment for uncomplicated falciparum malaria Azithromycin is a drug that has shown potential for malaria treatment It will be combined with other malaria drugs currently approved for treatment in Thailand About 120 people ages 20-65 will be enrolled in Thailand Participants will have severe cases of malaria and they will be hospitalized 28 days for treatment
Detailed Description:
The study is aimed at identifying a well tolerated practical and highly efficacious treatment regimen of azithromycin in combination with artesunate or quinine for uncomplicated falciparum malaria for future studies to monitor for the tolerability and safety of these combination regimens and to compare tolerability safety and efficacy of azithromycin when given in combination with artesunate as compared to quinine This study is also aimed at comparing tolerability safety and efficacy of the combination of artesunate and azithromycin when given as a single daily dose 200mg As1000mg Az for 3 days as compared to 2 doses of 100mg As750mg Az per day for 3 days and to compare the tolerability safety and efficacy of the combination of quinine and azithromycin when given as 3 daily doses of quinine 10mgkg Az 500mg vs 2 daily doses of quinine 10mgkg Az 750mg when given for 3 days
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A0661129 | None | None | None |