Seasonal Malaria Chemoprevention With Dihydroartemisin Piperaquin vs. Sulfadoxine-pyrimethamin+Amodiaquin

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Seasonal Malaria Chemoprevention (SMC) for children less than five years old is one the high impact interventions against malaria in sub-Saharan Africa (SSA). Since 2016, the Government of Mali and partners through the National Malaria Control Program has deployed SMC countrywide during high malaria transmission season with a total of four (4) rounds per year. Sulfadoxine-Pyrimethamine (SP) with Amodiaquine (AQ) are the drugs used for SMC. However, SP is also used for Intermittent preventative treatment (IPTp) for pregnant women while AQ has been used for decades for treatment of uncomplicated malaria.

The proposed study will examine the effect of SMC with Sulfadoxine+Amodiaquine (SP+AQ) extension to older age, the efficacy of Dihydroartemisin-Piperaquine (DHA-PQ) when used for SMC, social, cultural, economic and health systems factors associated with effective implementation of SMC. The specific aims of this study are to: 1] Assess the effect of SMC (SP+AQ) on malaria incidence and infection prevalence in different age groups across sites; 2] Study the effect of SMC (DHA-PQ) compared to SMC (SP-AQ) among children less than 10 years; 3] Determine the cost-effectiveness for each treatment regimen; ) 4] Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and 5) Establish a district based system to identify severe cases.

The expected outcomes of this work, upon completion of our specific aims, include 1) Recommendations to Malian health officials and other partners for improving implementation of SMC and alternative drug to SP+AQ for SMC, and 2) Guidelines for routine monitoring of SMC implementation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Clinical Research Center, Mali
• Collaborators: Deakin University; Johns Hopkins University; Tulane University; University of Copenhagen; University of South Florida
• Treatments: Amodiaquine; Artenimol; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Village resident (up to the end of the malaria transmission season)

• Age 3 months to 119 month age at the time of enrollment

• Parent or guardian provided consent for their child's participant (5-14 years old)

• Absence of chronic diseases, history of allergy to SP, AQ or DHA-PQ

Exclusion Criteria:

Non resident

• Age less than 3months or greater or equal to 119 months at the time of cohort enrollment

• Presence of chronic diseases, history of allergy to SP, AQ or DHA-PQ

• Does not provide consent/assent required according to age to participate in the study