NCT06300970

Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia

Efficacy of Artesunate-amodiaquine (ASAQ) and Artemether-lumefantrine (AL) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Liberia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.

Detailed description

Title: Efficacy of artesunate+amodiaquine (ASAQ) and artemether+lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia Objective: To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P. falciparum malaria infections Study Sites: Sacleapea Comprehensive Health Center, Saclepea-Mah District in Nimba County; and Sinje Health Center, Garwula District, Sinje, in Grand Cape Mount County Study Period: August 2022 to August 2023 Study Design: Prospective study of two cohorts with simultaneous enrolment of each therapy Patient population: Patients aged 6 to 59 months with confirmed uncomplicated P. falciparum infection Sample Size: Total number of patients to be enrolled is 352 patients. This consists of 88 patients per arm per site. There are two arms in each of the two sites. Treatment(s) and follow-up: Patients enrolled in the ASAQ arm will receive the treatment once daily dose for three days. Patients enrolled in the AL arm will receive treatment twice daily dose for three days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: The frequency and nature of adverse events will be recorded. Exploratory endpoints: Any polymorphisms of molecular markers for antimalarial drug resistance and prevalence of HRP2 deletions.

Conditions

• Plasmodium Falciparum
• Malaria
• Uncomplicated Malaria

Interventions

Type	Name	Description
DRUG	Amodiaquine-artesunate (ASAQ)	Oral medication given for treatment of uncomplicated plasmodium falciparum infection.
DRUG	Artemether+Lumefantrine (AL)	Oral medication given for treatment of uncomplicated plasmodium falciparum infection.

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-08-16
• Completion: 2023-08-16
• First posted: 2024-03-08
• Last updated: 2024-05-07

Locations

2 sites across 1 country: Liberia