None listed
Conditions
Brief summary
The study is a cluster-randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against malaria in human population in Southwest Sumba and to prove that impact associated with the entomological correlates. One hundred and eighty school age participants at the study site will be recruited and enrolled. Participants will be asked to complete a 14-day supervised malaria radical cure (regardless of blood film status at enrolment) consisting of concurrent dihydroartemisinin-piperaquine (3 days) and primaquine (14 days) immediately prior to the intervention. During the intervention, they will be asked to contribute a blood film once a week to check on their malaria status. All participants will be resident in Wainyapu village in Southwest Sumba District. Four clusters, 2 coastal and 2 inlands in the village will be will be randomly assigned to be given either active or placebo coils in double blinded fashion. Incident cases of slide-confirmed malaria among all residents will be monitored through passive case detection reporting to study clinics complaining of illness. Further, mass blood surveys will be conducted on a randomly selected sample of residents prior to, during, and at the end of the coil intervention. The team will distribute and light mosquito coils to each household in each cluster in order to ensure compliance and correct coil assignment. The primary endpoint will be the malaria attack rate among the radically cured school age children living in cluster with active versus placebo coils. Secondary endpoints will include rates of slide confirmed malaria among all residents according to coil assignment of the cluster they reside, along with human landing anopheline mosquitoes captured inside of homes analysed by active or placebo coil assignment.
Interventions
The study is a a cluster-randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against the malaria in human population in Southwest Sumba and to prove that impact associated with the entomological correlates.
Forty five school age participants (6-13 year old) in each of the four study clusters will be recruited and enrolled. Subjects will be asked to complete a supervised malaria radical cure (regardless of blood film status at enrolment) consisting
The study is a a cluster-randomized, double-blind, placebo-controlled trial to demonstrate the impact of spatial repellents against the malaria in human population in Southwest Sumba and to prove that impact associated with the entomological correlates. Forty five school age participants (6-13 year old) in each of the four study clusters will be recruited and enrolled. Subjects will be asked to complete a supervised malaria radical cure (regardless of blood film status at enrolment) consisting of dihydroartemisinin-piperaquine and primaquine prior to the coil intervention. We will give oral tablet of dihydroartemisinin (DHA) + piperaquine (PP) along with a single daily dose oral tablet of 0.6 mg/kg bodyweight (BW) primaquine (PQ) for 14 days. One tablet of DHA-PP contains 40mg of DHA and 320 mg of PP. It is administered based on body weight (BW) targeting a total dose of 6.4 and 51.2 mg/kg BW of dihydroartemisinin and piperaquine, respectively, given in three equally divided daily doses. All drugs will be administered with food and water. For Coil Intervention, each cluster in the village will be assigned to receive either active repellent (i.e. 0.0097% Metofluthrin) in a standard mosquito coil (manufactured to burn for 12 hours) or a placebo coil containing no known chemical repellent and being otherwise identical to the active coil with composition: Arm 1. 90 subjects in two cluster will be given insecticide-treated coil for 6 months. Arm 2. 90 subjects in two clusters will be given blank coil Each of the study areas (cluster) will be randomly assigned to be given either active or placebo coils for 6 months. Four coils will be placed in each house, and burned for 12 hours (commencing at 6PM each evening).
Sponsors
Eijkman Institute for Molecular Biology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
- Children between 6 - 13 years of age - Weight > 20 kg - G6PD normal on a qualitative screen - No severe anaemia - No significant chronic illness - Sleeps in village >90% of nights during any given month - No plans for extended travel during study - Willingness to sign informed consent
Exclusion criteria
- Having severe / chronic disease - G6PD deficiency
Outcome results
None listed