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

0900f3eb81e634a9

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.

2022-08-09

2023-08-16

2023-08-16

Completed

Early phase I

352

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 on Day 0 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 352, 'type': 'ACTUAL'}}

2024-05-07