Phase 3
Completed N=780
Intermittent Preventive Treatment of Malaria in Schoolchildren
Malaria · Intermittent Preventive Treatment
Source: ClinicalTrials.gov NCT00852371 ↗
Enrolled (actual)
780
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Risk of Parasitaemia (Unadjusted by Genotyping) — 23; 87; 164; 147 Participants
◆ Published Evidence
Established
63citations · ~4 / year
Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren.
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.
Linked Publications
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Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk of Parasitaemia (Unadjusted by Genotyping) |
23; 87; 164; 147 | — |
| SECONDARY Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment |
2; 6; 64; 50 | — |
| SECONDARY Risk of New Infection (Adjusted by Genotyping) in All Participants |
12; 55; 64; 62 | — |
| SECONDARY Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment |
2; 6; 64; 50 | — |
| SECONDARY Mean Change in Haemoglobin |
0.34; 0.37; 0.24; 0.18 | — |
| SECONDARY Risk of Serious Adverse Events |
117; 122; 125; 114 | — |
| SECONDARY Acceptability of IPT Regimens |
55; 67; 20; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 8 to 10,000/ul
Data sourced from ClinicalTrials.gov (NCT00852371) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.