Clinical trial NCT00852371: Intermittent Preventive Treatment of Malaria in Schoolchildren
Official title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Intermittent Preventive Treatment
Keywords: Malaria
Intermittent preventive treatment
Efficacy
Safety
Tolerability
Schoolchildren
Uganda
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Uganda Malaria Surveillance Project
name: Ministry of Health, Uganda
First posted: 2009-02-27
Enrollment: 780
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The study will be carried out among children aged ≥ 8 to \< 14 years (boys) and ≥ 8 to \< 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 8 to \< 14 years (boys), ≥ 8 to \< 12 years (girls)
* Student enrolled at participating school in classes 3-7
* Provision of informed consent from parent or guardian
* Provision of assent by student

Exclusion Criteria:

* Known allergy or history of adverse reaction to study medications
* Onset of menstruation (girls)
* Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
* Evidence of severe malaria or danger signs
* Haemoglobin \< 7.0 gm/dL
* Parasite density \> 10,000/ul

Primary outcomes:
measure: Risk of Parasitaemia (Unadjusted by Genotyping)
timeFrame: after 42 days of follow-up
Secondary outcomes:
measure: Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment
timeFrame: after 42 days of follow-up
measure: Risk of New Infection (Adjusted by Genotyping) in All Participants
timeFrame: after 42 days of follow-up
measure: Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment
timeFrame: Over 42 days of follow-up
measure: Mean Change in Haemoglobin
timeFrame: Between day 0 to day 42
measure: Risk of Serious Adverse Events
timeFrame: over 42 days of follow-up
measure: Acceptability of IPT Regimens
timeFrame: on day 7
measure: Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment
timeFrame: after 42 days of follow-up
Other outcomes:
Locations:
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Sarah G Staedke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren. PLoS One. 2010 Oct 19;5(10):e13438. doi: 10.1371/journal.pone.0013438.