Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren

Phase 3 Completed 616 enrolled University of Antwerp Fund for Scientific Research, Flanders, Belgium · collab University of Kinshasa · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

Considering the facts that: (i) IPT of malaria provides substantial protection against anaemia and malaria in school children (ii); SP resistance has no significant impact on the prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration, reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and school performance in school-aged children of Congo.

Timeline

Start: 2012-11
Primary completion: 2013-11
Completion: 2013-11

Publications

Doua JY, Matangila J, Lutumba P, Van Geertruyden JP. Intermittent preventive treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine regimens in schoolchildren of the Democratic Republic of Congo: a study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:311. doi: 10.1186/1745-6215-14-311.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sulfadoxine-pyrimethamine	Small molecule	25 mg	Oral
Subject	Sulfadoxine-pyrimethamine	Small molecule	500 mg	Oral
Subject	piperaquine	Small molecule	16 mg/kg	—
Subject	piperaquine	Small molecule	24 mg/kg	—
Background	Albendazole	Small molecule	200 mg	Oral
Background	Albendazole	Small molecule	400 mg	Oral
Background	Praziquantel	Small molecule	40 mg/kg	—

Indications

No indication recorded.