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Innovative Intermittent Preventive Treatment Approaches to Reduce Malaria Burden in School-age Children in Burkina Faso

NCT05946642 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13000

Last updated 2023-11-22

No results posted yet for this study

Summary

This will be an open label cluster randomized study with two active intervention and one control arm. A cluster will be defined as a selected village. One district implementing seasonal malaria chemoprevention (SMC) will be selected, and six villages will be randomly selected in this district. These six villages will be randomly allocated to each of the three study arms; 1) Arm 1 will receive IPTsc with sulphadoxine-pyrimethamine plus amodiaquine (SPAQ); and 2) Arm 2 will receive dihydroartemisinin-piperaquine (DP) plus Ivermectin (IVM), all given monthly during the transmission season and 3) Control Arm which will have standard malaria control measures including case management and vector control measures as applicable.

Conditions

Interventions

DRUG

Sulphadoxine-Pyrimethamine/Amodiaquine

Co-blister packaging of sulfadoxine-pyrimethamine (SP) dispersible tablets administered on the first day and amodiaquine (AQ) dispersible tablets administered once daily for three days. The dose of SPAQ will be determined according to the child's age.

DRUG

Dihydroartemisinin/Piperaquine (DP) plus Ivermectin (IVM)

DP will consist of tablets containing 320/40 mg and 160/20 mg piperaquine/dihydroartemisinin per tablet. A full course of DP should be administered in accordance with the manufacturer's instructions, once a day for 3 days, according to body weight. DP should be taken orally with water and without food. It will be given in association with Ivermectin. Ivermectin (IVM) will be available as 3 mg or 6 mg tablets to be administered at the doses of 300- 400μg/kg/day for 3 days (to the nearest whole tablet). IVM should also be taken with water on an empty stomach.

Sponsors & Collaborators

  • Malaria Consortium

    lead OTHER

Principal Investigators

  • Jane Achan, PhD · Malaria Consortium

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2024-05-31
Completion
2024-12-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946642 on ClinicalTrials.gov