Intermittent Preventive Treatment of Malaria in Schoolchildren
Information source: Gates Malaria Partnership
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria; Intermittent Preventive Treatment
Intervention: sulfadoxine-pyrimethamine (Drug); amodiaquine + sulfadoxine-pyrimethamine (Drug); dihydroartemisinin-piperaquine (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Gates Malaria Partnership Official(s) and/or principal investigator(s): Sarah G Staedke, MD, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine
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.
Clinical Details
Official title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Risk of parasitaemia (unadjusted by genotyping)
Secondary outcome: Risk of recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollmentRisk of new infection (adjusted by genotyping) in all children Risk of clinical failure due to recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollment Risk of parasitological failure due to recrudescence (adjusted by genotyping) in children who were parasitaemic at enrollment Mean haemoglobin Mean change in haemoglobin Risk of serious adverse events Risk of all adverse events Acceptability of IPT regimens
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
Minimum age: 8 Years.
Maximum age: 13 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 2008
Last updated: February 26, 2009
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