About this trial
The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of all ages in surrounding communities.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Child currently attending the participating school.
Agreement of parent/guardian to provide informed consent.
Agreement of children aged 8-17 years to provide assent.
Disqualifiers
Missing school on three consecutive days of the school survey.
Trial design
Parallel
Treatments tested in this trial
dihydroartemisinin-piperaquine
DrugD-Artepp, is manufactured by Guilin Pharmaceutical Co Ltd, and is prequalified by the WHO and approved for use in Uganda by the National Drug Authority. Standard treatment doses of DP (once a day x 3 days) will be administered using weight-based guidelines targeting a total dose of 6.4 mg/kg dihydroartemisinin and 51.2 mg/kg of piperaquine as per manufacturer's instructions.
Treatment groups
Trial outcomes
Primary outcomes
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages over the 24-month intervention period
Secondary outcomes
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area after the intervention is competed
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages 12 months after intervention is completed
Parasite prevalence among community residents 12 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
Parasite prevalence among community residents 24 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
Parasite prevalence among community residents 12 months after the intervention is completed
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Infectious Diseases Research Collaboration, Uganda
Collaborator
Ministry of Health, Uganda
Collaborator
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