Status:
COMPLETED
Intermittent Preventive Treatment of Malaria in Schoolchildren
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Uganda Malaria Surveillance Project
Ministry of Health, Uganda
Conditions:
Malaria
Intermittent Preventive Treatment
Eligibility:
All Genders
8-13 years
Phase:
PHASE3
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 s...
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 samp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT00852371
Start Date
February 1 2008
End Date
June 1 2008
Last Update
March 21 2024
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