NCT00677833

Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	Azithromycin plus Chloroquine	Combination of Azithromycin plus Chloroquine Azithromycin (\~30 mg/kg) + chloroquine (\~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
DRUG	Artemether-lumefantrine	Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-05-15
• Last updated: 2014-06-26
• Results posted: 2014-06-26

Locations

7 sites across 5 countries: Burkina Faso, Côte d’Ivoire, Ghana, Kenya, Mali