At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
In Brief
A Phase 3 clinical trial evaluating sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine, and 2 other interventions for Malaria and Intermittent Preventive Treatment. Completed, enrolled 780 participants.
Detailed Summary
This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.
Study Details
Timeline
Interventions
25 mg/kg po once on day 0
Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
dosed as for amodiaquine (10mg/kg po daily on days 1, 2)