Malaria
Conditions
Interventions
Artemether Lumefantrine
Sponsors
Macha Research Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 6 months and 5 years (i.e. up to 59 months of age) Mono-infection with P. falciparum detected by microscopy Parasitaemia of 2,000 to 200,000 /µl asexual forms Presence of axillary or tympanic temperature = 37.5 °C or oral or rectal temperature of = 38 °C, or history of Ability to swallow oral medication Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule Written informed consent from a parent or guardian
Exclusion criteria
Exclusion criteria: Presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO as adapted to the clinic setting Mixed or mono-infection with another Plasmodium species detected by microscopy Presence of severe malnutrition defined as a child whose growth (wt for age) is below –3 Z-score Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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 artemether-lumefantrine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic response | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasite clearance;Parasite drug resistance genotype;Lumefantrine pharmacokinetics | — |
Countries
Zambia
Contacts
Public ContactPhilip Thuma
Senior Scientific Director
Outcome results
None listed