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

Malaria Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

• NCT number: NCT01755559
• Study type: Interventional
• Source: Epicentre
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Completion date: November 2014