Efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Siaya and Bungoma Counties, Kenya

IRB00012257

WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Kenya Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether lumefantrine (AL), and dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated malaria in Kenya. The objective of this study is to inform the decisions or actions made by a public health authority (Kenya Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in the treatment of children with uncomplicated malaria. The study is being conducted by Kenya MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.

2021-03-15

2022-12-18

2022-12-18

Completed

Early phase I

400

Inclusion Criteria: * age between 6 months to 59 months; mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); * parasitaemia of 1,000 - 100,000/µl asexual forms; * presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h; * ability to swallow oral medication; * haemoglobin ≥5.0 g/dL at admission; * informed consent from a parent or guardian; * parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, and 28 Exclusion Criteria: * general danger signs or signs of severe falciparum malaria according to the definitions of WHO; * severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition; * mixed or mono-infection with another Plasmodium species detected by microscopy; * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); * regular medication, which may interfere with antimalarial pharmacokinetics; * history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); * history of receiving any antimalarial treatment in the preceding 72 hours;. exposure to malaria vaccine

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The two drugs being assessed are already approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatments for malaria. The study is to assess the continued efficacy of the drugs.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}}, 'enrollmentInfo': {'count': 400, 'type': 'ACTUAL'}}

2023-11-01