Randomized Field Trial to Assess the Safety and Efficacy of Dihydroartemisinin-Piperaquine for Seasonal Malaria Chemoprevention in School-Aged Children in Bandiagara, Mali

J Infect Dis. 2024 Jan 12;229(1):189-197. doi: 10.1093/infdis/jiad387.

Abstract

Background: Owing to the increased cases of malaria in older children, the World Health Organization has recently recommended extending seasonal malaria chemoprevention (SMC) to children >5 years of age and using other effective drugs for malaria. In this study, we report the safety and efficacy of dihydroartemisinin-piperaquine (DHA-PQ) for SMC in school-aged children in Mali.

Method: This randomized, controlled trial included 345 participants aged 6-15 years randomized to receive DHA-PQ, sulfadoxine-pyrimethamine plus amodiaquine (SP-AQ), or no chemoprevention (albendazole) at a 1:1:1 ratio. Four rounds of SMC were conducted from September to December 2021. The participants were assessed 7 days after each round for safety and efficacy of the interventions.

Results: Abdominal pain (11.8% vs 29.2%), headache (11.2% vs 19.2%), and vomiting (5.7% vs 15.2%) were frequently reported in the DHA-PQ and SP-AQ arms. On Day 120 of follow up, the incidence of clinical malaria was 0.01 episodes/person-month in the DHA-PQ and SP-AQ arms and 0.17 episodes/person-month in the control arm (P < .0001). Gametocytes were detected in 37 participants in all arms.

Conclusions: Children in DHA-PQ arm reported less adverse events compared to the SP-AQ arm. Both drugs were effective against clinical malaria and infection.

Keywords: DHA-PQ; Mali; SMC; malaria; school-aged children.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amodiaquine / adverse effects
  • Antimalarials* / adverse effects
  • Artemisinins*
  • Chemoprevention / adverse effects
  • Child
  • Child, Preschool
  • Drug Combinations
  • Humans
  • Infant
  • Malaria* / epidemiology
  • Mali / epidemiology
  • Piperazines*
  • Quinolines*
  • Seasons
  • Sulfadoxine / adverse effects

Substances

  • artenimol
  • Antimalarials
  • piperaquine
  • Sulfadoxine
  • Amodiaquine
  • Drug Combinations
  • Piperazines
  • Quinolines
  • Artemisinins