Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dihydroartemisinin-piperaquine.
- Who it may be relevant to
- Registry conditions: Malaria. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission
Overview
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.
Detailed description
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.
Interventions
- Drug dihydroartemisinin-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.
Primary outcome measures
- Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented [Time frame: 24 months after intervention implemented]
Secondary outcome measures (12)
- Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area after the intervention is competed [Time frame: 12 months after intervention is completed]
- Parasite prevalence among community residents 12 months after the intervention is implemented [Time frame: 12 months after the intervention is implemented]
- Parasite prevalence among community residents 24 months after the intervention is implemented [Time frame: 24 months after the intervention is implemented]
- Parasite prevalence among community residents 12 months after the intervention is completed [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 [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 [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 [Time frame: 12 months after the intervention is completed]
- Parasite prevalence among schoolchildren 12 months after the intervention is implemented [Time frame: 12 months after the intervention is implemented]
- Parasite prevalence among schoolchildren 24 months after the intervention is implemented [Time frame: 24 months after the intervention is implemented]
- Parasite prevalence among schoolchildren 12 months after the intervention is completed [Time frame: 12 months after the intervention is completed]
- Anemia prevalence among schoolchildren 12 months after the intervention is implemented [Time frame: 12 months after the intervention is implemented]
- Anemia prevalence among schoolchildren 24 months after the intervention is implemented [Time frame: 24 months after the intervention is implemented]
Eligibility criteria
Inclusion criteria
- Child currently attending the participating school.
- Agreement of parent/guardian to provide informed consent.
- Agreement of children aged 8-17 years to provide assent.
Exclusion criteria
- Missing school on three consecutive days of the school survey.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Uganda · 1 center
- Infectious Diseases Research Collaboration — Kampala
Identifiers
NCT: NCT07246525 · CRITICal · U01AI186861