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

ConditionMalaria
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • dihydroartemisinin-piperaquine

    Drug

    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.

Treatment groups

4,800 Participants
are divided into 2 treatment groups
Group A: IPTscExperimental treatment 1 intervention
Group B: No IPTscNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: