A Phase 4 interventional study of dihydroartemisinin-piperaquine in Malaria, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in Uganda. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Prevention
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.
The CRITICal study is an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc. The intervention will be delivered for 2 years and evaluations will continue for 1 additional year after the intervention is stopped. The primary outcome of the study will be malaria incidence within the population of the target areas. Secondary outcomes will include the the prevalence of parasitemia and molecular markers of DP resistance at the community level; the prevalence of parasitemia, anemia, and school attendance among children attending primary school; and estimates of the cost-effectiveness of IPTsc.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 4,800 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DP will be administered approximately every 2 months for two years to all eligible children enrolled in primary schools serving the target areas from clusters randomized to the interventional arm.
Drug: dihydroartemisinin-piperaquine
No IPTsc (standard of care)
Drug pages: Artenimol · Piperaquine
D-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.
Also known as: D-Artepp
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
Time frame: 24 months after intervention implemented
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
Time frame: 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
Time frame: 12 months after the intervention is implemented
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
Time frame: 24 months after the intervention is implemented
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
Time frame: 12 months after the intervention is completed
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is implemented
Proportion of parasite positive samples with molecular markers of DP resistance detected
Time frame: 12 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 24 months after the intervention is implemented
Proportion of parasite positive samples with molecular markers of DP resistance detected
Time frame: 24 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is completed
Proportion of parasite positive samples with molecular markers of DP resistance detected
Time frame: 12 months after the intervention is completed
Parasite prevalence among schoolchildren 12 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
Time frame: 12 months after the intervention is implemented
Parasite prevalence among schoolchildren 24 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
Time frame: 24 months after the intervention is implemented
Parasite prevalence among schoolchildren 12 months after the intervention is completed
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
Time frame: 12 months after the intervention is completed
Anemia prevalence among schoolchildren 12 months after the intervention is implemented
Proportion of children with anemia at the time of school surveys Anemia defined based on WHO criteria as: 1. hemoglobin less than 11.5g/dl in children 5 - 11 years of age; 2. hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and 3. hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
Time frame: 12 months after the intervention is implemented
Anemia prevalence among schoolchildren 24 months after the intervention is implemented
Proportion of children with anemia at the time of school surveys Anemia defined based on WHO criteria as: 1. hemoglobin less than 11.5g/dl in children 5 - 11 years of age; 2. hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and 3. hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
Time frame: 24 months after the intervention is implemented
Anemia prevalence among schoolchildren 12 months after the intervention is completed
Proportion of children with anemia at the time of school surveys Anemia defined based on WHO criteria as: 1. hemoglobin less than 11.5g/dl in children 5 - 11 years of age; 2. hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and 3. hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
Time frame: 12 months after the intervention is completed
Plan to share: No
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Studies of the drugs tested here: Artenimol · Piperaquine
University of California, San Francisco →