Malaria
Conditions
Interventions
Artesunate pyronaridine treatment arm
Artemether lumefantrine treatment arm
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 6 months to 10 years; 2. Mono-infection with P. falciparum confirmed by positive blood smear; 3. Asexual parasite density of 1,000 to 200,000 per µl; 4. Presence of axillary temperature = 37.5 °C or history of fever during the past 24 hours; 5. Ability to swallow oral medication; 6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; 7. Informed consent from parent or guardian and assent from children aged 8-10 years; 8. Haemoglobin > 8.0 g/dl
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs or signs of severe falciparum malaria according to the WHO definition (Appendix 1); 2. Weight under 5 kg; 3. Mixed or mono-infection with another Plasmodium species as detected by microscopy; 4. Presence of severe malnutrition defined as a very low weight for height (below -3z scores of the median WHO growth standards), by visible severe wasting, by the presence of nutritional oedema, or in a child aged between 6-60 months who has a mid-upper arm circumference < 115 mm; 5. 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); 6. Regular medication, which may interfere with antimalarial pharmacokinetics (ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carini pneumonia in children born to HIV positive women); 7. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 42 day cure rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with parasites on days 1-3 after treatment. • Proportion of patients with fever on day 3 after treatment. • Prevalence of gametocytes on day 0-42. • Prevalence of P. falciparum genetic polymorphisms associated with antimalarial drug resistance. • Parasite clearance half-life. | — |
Countries
Uganda
Contacts
Public ContactBridget Nzarubara
Regulatory Officer
Outcome results
None listed