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

NCT ID: NCT06300970

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2023-08-16

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate+Amodiaquine (ASAQ)

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

Group Type: ACTIVE_COMPARATOR

Amodiaquine-artesunate (ASAQ)

Intervention Type: DRUG

Oral medication given for treatment of uncomplicated plasmodium falciparum infection.

Artemether+Lumefantrine (AL)

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

Group Type: ACTIVE_COMPARATOR

Artemether+Lumefantrine (AL)

Intervention Type: DRUG

Oral medication given for treatment of uncomplicated plasmodium falciparum infection.

Interventions

Amodiaquine-artesunate (ASAQ)

Oral medication given for treatment of uncomplicated plasmodium falciparum infection.

Intervention Type: DRUG

Artemether+Lumefantrine (AL)

Oral medication given for treatment of uncomplicated plasmodium falciparum infection.

Intervention Type: DRUG

Other Intervention Names

ASAQ; Camoquin; AL; Coartem

Eligibility Criteria

Inclusion Criteria

1. Age between 6 to 59 months (5 years)

2. Weight ≥ 5 kg

3. Monoinfection with P. falciparum with a parasite density of 2,000 to 200,000 asexual forms per microliter of blood

4. Axillary temperature ≥37.5˚C or history of fever in the last 24 hours

5. Hemoglobin ≥ 8.0g/dl

6. Easy access to the health facility and ability to return to the health facility over the course of the four weeks of follow-up

7. Informed consent of parent or guardian

Exclusion Criteria

1. Any danger signs or signs of severe malaria (see Appendix I)

2. Pneumonia or bronchopneumonia

3. Severe malnutrition (Z-score < 3)

4. History of taking antimalarials (or antibiotics with antimalarial activity such as cotrimoxazole, tetracycline or doxycycline) in the last 14 days

5. Mixed malaria infection

6. History of hypersensitivity or allergy to the medication

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Liberia

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Jonathan Schultz

Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor S Koko

Role: PRINCIPAL_INVESTIGATOR

Liberia National Malaria Control Program

Locations

Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County

Sinje, Grand Cape Mount County, Liberia

Saclepea-Mahn Comprehensive Health Center Saclepea-Mahn District, Nimba County

Saclepea, Nimba, Liberia

Countries

Liberia

Other Identifiers

0900f3eb81e634a9

Identifier Type: -

Identifier Source: org_study_id