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

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.

Timeline

Start

2008-06

Primary completion

2010-09

Completion

2010-09

Outcome

Missed primary endpoint

paper CONCLUSIONS: In this study, non-inferiority of AZCQ to AL was not demonstrated. PMID 25881046 ↗

registry ACPR percent difference -9.10 (95% CI -16.02 to -2.18) NCT00677833 ↗

registry ACPR percent difference -6.08 (95% CI -12.10 to -0.05) NCT00677833 ↗

Publications

• Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, Ogutu B. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study. Malar J. 2015 Mar 10;14:108. doi: 10.1186/s12936-015-0620-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artemether-lumefantrine	Unknown	—	—
Subject	Azithromycin	Small molecule	30 mg/kg	—
Subject	Chloroquine	Small molecule	10 mg/kg	—

Indications