Phase 3
N=780
Intermittent Preventive Treatment of Malaria in Schoolchildren
Malaria · Intermittent Preventive Treatment
Bottom Line
View on ClinicalTrials.gov: NCT00852371 ↗Enrolled (actual)
780
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Risk of Parasitaemia (Unadjusted by Genotyping) — 23; 87; 164; 147 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sulfadoxine-pyrimethamine (Drug); amodiaquine + sulfadoxine-pyrimethamine (Drug); dihydroartemisinin-piperaquine (Drug); Placebo (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- London School of Hygiene and Tropical Medicine
- Primary completion
- Jun 2008
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 | — |
| SECONDARY Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment |
2; 6; 64; 50 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 8 to 10,000/ul
Data sourced from ClinicalTrials.gov (NCT00852371). 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.