Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Phase 3 Terminated 2891 enrolled Pfizer London School of Hygiene and Tropical Medicine · collab Medicines for Malaria Venture · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

Timeline

Start: 2010-10
Primary completion: 2013-10
Completion: 2013-11

Publications

Mtove G, Kimani J, Kisinza W, Makenga G, Mangesho P, Duparc S, Nakalembe M, Phiri KS, Orrico R, Rojo R, Vandenbroucke P. Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings. Trials. 2018 Mar 22;19(1):190. doi: 10.1186/s13063-018-2563-1.
Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	1000 mg	Oral
Subject	Chloroquine	Small molecule	620 mg	Oral
Comparator	pyrimethamine	Small molecule	75 mg	Oral
Comparator	sulfadoxine	Small molecule	1500 mg	Oral

Indications

No indication recorded.