Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission (CRITICal)

University of California San Francisco (UCSF)

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Malaria

Treatments: Drug: dihydroartemisinin-piperaquine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07246525

CRITICal

U01AI186861 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,800 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,800 participants in 2 patient groups

IPTsc

Experimental group

Description:

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.

Treatment:

Drug: dihydroartemisinin-piperaquine

No IPTsc

No Intervention group

Description:

No IPTsc (standard of care)