Malaria
Conditions
Interventions
Artemether - lumefantrine tablets
Sponsors
Medical Research Council Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 1 year to 12 years 2. Mono-infection with P. falciparum determined by microscopy 3. Parasite density between 1000 and 100,000/µl asexual forms 4. Axillary temperature ¿ 37.5 °C and/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; resident in the study area for the duration of the study and willing to come for all scheduled study visits 7. Informed consent from the caregiver (parent or guardian).
Exclusion criteria
Exclusion criteria: 1.Danger signs or signs of severe falciparum malaria based on standard WHO 2.Mixed infection with Plasmodium species other than falciparum determined by microscopy. 3.Severe malnutrition defined by a very low weight for age (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema. 4.Other identifiable cause for the fever (e.g. measles, acute respiratory tract infection) 5.Long term regular medication, which may interfere with antimalarial pharmacokinetics; such as for TB, HIV, cardiac disease. 6.History of hypersensitivity or contraindications to any component of the medicine being tested.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parassite clearance time measured;Parassite clearance time measured;1.The proportion of children with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy;3.Ex-vivo susceptibility of parasites to ACT partner drugs ;3.Ex-vivo susceptibility of parasites to ACT partner drugs | — |
Countries
Gambia
Contacts
Public ContactMarie Rose Thorpe
Project Administrator
Outcome results
None listed