Malaria Therapeutic Efficacy Study, Rwanda

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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, Rwanda Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether-lumefantrine (ALN), which has been used in Rwanda for the last 14 years) and dihydroartemisinin-piperaquine (DHA-PPQ), another WHO-approved drug for the treatment of uncomplicated malaria which, though, has not been used in Rwanda, is being considered for adoption as a second line or alternative first line treatment. The objective of this study is to inform the decisions or actions made by a public health authority (Rwanda Rwanda Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Rwanda. Jhpiego's Impact Malaria project in Rwanda, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Rwanda MOH in its effort to evaluate the efficacy of ALN and DHA-PPQ in the treatment of children with uncomplicated malaria. The study is being conducted by Rwanda MOH, with technical support and funding by PMI-USAID through Jhpiego in Rwanda.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jhpiego
• Collaborators: Centers for Disease Control and Prevention; Ministry of Health, Rwanda; United States Agency for International Development (USAID)
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Artenimol; Dihydroartemisinin; Lumefantrine; Piperaquine

Criteria

Inclusion Criteria:

• Children aged 6 months to 59 months old

• Monoinfection with P. falciparum and parasitaemia of 1,000 - 100,000 asexual parasites per µl

• Axillary temperature 37.5 °C or history of fever in the preceding 24 hours before recruitment

• Ability to swallow oral medication

• Haemoglobin ≥7.0 g/dL at admission

• Informed consent from guardian/parent of patient

• Parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, and 42 (35 and 42 in DHA-PPQ arm only)

• Ability for the child to be admitted to a health center for inpatient blood testing, observation and treatment for three days

Exclusion Criteria:

• Danger signs of severe malaria or signs of severe malaria

• Other underlying diseases (cardiac, renal, hepatic diseases)

• Severe malnutrition according to WHO child growth standards (WHO, 2006), children - with marasmus or oedematous malnutrition

• History of allergy to study drugs

• A clear history of receiving any antimalarial treatment in the preceding 72 hours

• Ongoing prophylaxis with drugs having antimalarial activity, such as cotrimoxazole for the prevention of Pneumocisti jirovici pneumonia in children born to HIV+ women