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

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.

Conditions

• Malaria,Falciparum

Interventions

DRUG

Sulfadoxine pyrimethamine + Amodiaquin

Monthly dose of SPAQ over three days for SMC

DRUG

Dihydroartemisinin piperaquin

Monthly dose of DHAPQ for SMC

Sponsors & Collaborators

• Tulane University

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Deakin University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University Clinical Research Center, Mali

  lead OTHER

Principal Investigators

• Seydou Doumbia, PhD · University Clinical Research Center - USTTB - Mali

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

3 Months

Max Age

119 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2022-12-31

Completion

2023-12-30

Countries

• Mali

Study Locations