NCT00299208

Azithromycin Combination Therapy for Malaria

Phase II, Open Label, Randomized Study of Azithromycin Combination Therapy for the Treatment of Acute, Uncomplicated Falciparum Malaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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 As+1000mg Az) for 3 days as compared to 2 doses of 100mg As+750mg 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 (10mg/kg) + Az 500mg vs. 2 daily doses of quinine (10mg/kg) + Az 750mg when given for 3 days.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artesunate
DRUG	Azithromycin
DRUG	Quinine

Timeline

• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2006-03-06
• Last updated: 2010-08-27

Locations

1 site across 1 country: Thailand