Malaria
Conditions
Interventions
Artemether Lumefantrine
Dihydroartesiminin Piperaquine
Sponsors
PATH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 6 months to 10 years. 2. Mono-infection with P. falciparum confirmed by positive blood film (i.e., No mixed infection). 3. Parasitaemia of 1,000 – 100,000/µl asexual forms. 4. Presence of axillary temperature = 37.5°c or history of fever during the past 24 hours. 5. Ability to swallow and retain oral medication. 6. Haemoglobin =8.0 g/dL. 7. Informed consent from a parent or guardian. 8. Parent or guardian agrees to bring the child for the completion of AL or DHP doses and planned follow-up visits on days 7, 14, 21, 28, 35, and 42. Parent or guardian also agrees to bring the child back to the clinic (or agrees to hospitalization for three days) to ensure administration of all doses of treatment, or have a community health promoter (CHP) or study staff visit them at home to administer all evening doses of AL. 9. Live or plan to stay within the catchment area (within a 15 km radius of the sub-county hospital) of the study site for the next three months. 10. Ability and willingness to comply with the protocol for the duration of the study. 11. Parent or caregiver has access to a phone so that study staff may contact them during study period for visit reminders. 12. Children who have received the malaria vaccine (RTS,S/R21) or monoclonal antibody (L9LS) in the study area will be eligible to participate, but vaccination status will not be an inclusion or exclusion criterion. Receipt of either of these preventative pharmaceutical interventions will be recorded at enrollment.
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs or signs of severe P. falciparum malaria according to the definitions of WHO (Appendix 2). 2. History of receiving any antimalarial treatment or antibiotics with antimalarial activity in the preceding 2 weeks from any source outside the study team. 3. Weight < 5 kg. 4. Haemoglobin < 8g/dL. 5. Mixed or mono-infection with another Plasmodium species detected by microscopy. 6. Presence of severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or edematous malnutrition. 7. 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, sickle cell disease). 8. Medication, which may interfere with antimalarial pharmacokinetics. These include antiretroviral drugs, anti-epileptic drugs, certain anti-fungal and anti-TB medications (List in Appendix 4) 9. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s). 10. Regular antimalarial use for prophylaxis. These include use for malaria chemoprevention, e.g., in sickle cell disease, post-discharge malaria chemoprevention, etc. 11. Participating in another clinical trial. 12. Plan to travel or leave the study catchment area within the next three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the therapeutic efficacy of Artemether-Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated P. falciparum malaria. 2. To measure the clinical and parasitological efficacy of AL and DHP in patients aged between 6 months and 10 years, diagnosed with uncomplicated P. falciparum malaria by determining the proportion with early treatment failure, late clinical failure, late parasitological failure, or adequate clinical and parasitological response as indicators of efficacy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the frequency of existing molecular markers associated with anti-malarial drug resistance, identify new molecular markers, and frequency of evasion of HRP2-based rapid diagnostic tests (RDT). 2. To evaluate the incidence of adverse/severe adverse events after treatment with AL and DHP. 3. Evaluate duration of malaria HRP2/pLDH RDT positivity after appropriate treatment with AL and DP (if funding allows) | — |
Countries
Kenya
Contacts
Public ContactSamuel Mahugu
National Malaria Control Programme
Outcome results
None listed