A Phase 4 interventional study of Amodiaquine-artesunate (ASAQ) and Artemether+Lumefantrine (AL) in Plasmodium Falciparum, Malaria and Uncomplicated Malaria, sponsored by Centers for Disease Control and Prevention. Completed at 2 sites in Liberia. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Centers for Disease Control and Prevention · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria on Day 0
Amodiaquine-artesunate (ASAQ) dose based on weight, given once daily for three days. ASAQ has three formulations, with the dose depending on the weight of the child according to the following. 4.5-8.9 kg = 1 tablet 25 mg AS/67.5 mg AQ 9-17.9kg = 1 tablet 50 mg AS/135 mg AQ 18.0-35.9kg = 1 tablet 100 mg AS/270 mg AQ ≥36.0kg = 2 tablets 100 mg AS/270 mg AQ
Drug: Amodiaquine-artesunate (ASAQ)
Artemether+Lumefantrine (AL) dose is based on weight and given twice daily for three days. AL has one formulation, with pills containing 20 mg artemether and 120 mg lumefantrine. The number of tablets per dose depends on the weight of the child according to the following: 5 -14.9 kg = 1 tablet per dose 15 -24.9 kg = 2 tablets per dose 25 -34.9 kg = 3 tablets per dose ≥35 kg = 4 tablets per dose 1 tablet contains 20 mg artemether and 120 mg lumefantrine
Drug: Artemether+Lumefantrine (AL)
Oral medication given for treatment of uncomplicated plasmodium falciparum infection.
Also known as: ASAQ, Camoquin
Oral medication given for treatment of uncomplicated plasmodium falciparum infection.
Also known as: AL, Coartem
Number of Participants with Early Treatment Failure (ETF)
* Danger signs or severe malaria on day 1, 2, or 3 in the presence of parasitemia * A parasitemia on day 2 higher than day 0 * Axillary temperature ≥ 37.5 °C on day 3 in the presence of parasitemia * Parasitemia on day 3 ≥ 25% of day 0 parasitemia
Time frame: Day 1 to day 3 following treatment.
Number of Participants with Late Treatment Failure (LTF)
* Danger signs, signs of severe malaria, or axillary temperature \> 37.5 °C in the presence of parasitemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure * Presence of parasitemia (with a parasite with the same genotype as day 0) on any day between day 7 and day 28 regardless of temperature in patients who did not previously meet any of the criteria of early treatment failure
Time frame: Day 4 to day 28 following treatment.
Number of Participants with Adequate Clinical and Parasitological Response (APCR)
• Absence of parasitemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure, reinfection or late parasitological failure.
Time frame: Day 28 following treatment.
Number of Patients with Adverse Events
An adverse event is defined as any unfavorable, unintended sign, symptom, syndrome or disease that develops or worsens with the use of a medicinal product, regardless of whether it is related to the medicinal product during participation in the study, approximately 4 weeks.
Time frame: During participation in the study, approximately 4 weeks.
Number of samples with confirmed Histidine-rich protein 2/3 (HRP2/3) gene deletions
Molecular data on hrp2/hrp3 deletions will be tabulated and frequencies will be calculated from samples collected during the study, approximately 4 weeks.
Time frame: Samples collected from participants during the study, approximately 4 weeks.
Number of samples with molecular markers of anti-malarial resistance
Molecular data on drug resistance polymorphisms will be tabulated and frequencies will be calculated from samples collected during the study, approximately 4 weeks.
Time frame: Samples collected from participants during the study, approximately 4 weeks.
Plan to share: Yes — IPD should be requested from the Liberian Ministry of Health
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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