NCT01755559

Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger

Efficacy of Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine Combination Therapies for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Aged 6 to 59 Months in Maradi, Niger 2012-13

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 663 (actual)
• Sponsor: Epicentre · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

Study treatments: * Artemether-lumefantrine * Artesunate-amodiaquine * Dihydroartemisinin-piperaquine Location: Maradi, Niger Principal Objective: To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment. Secondary objectives: * To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7 * To assess the incidence of adverse events during the follow-up period; * To measure speed of parasite clearance Methods: In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component. Target population: Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi. Sample size: 221 patients per study treatment; 663 patients in total. Treatment allocation: Random. Outcomes: * Early treatment failure, * Late clinical failure, * Late parasitological failure, * Adequate clinical and parasitological response. Analysis: * Cumulative success or failure rate (Kaplan-Meier analysis). * Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Artesunate-amodiaquine	antimalarial ACT
DRUG	Dihydroartemisinin-piperaquine	antimalarial ACT
DRUG	Artemether-lumefantrine	antimalarial ACT

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-12-24
• Last updated: 2015-11-30

Locations

1 site across 1 country: Niger