Malaria Infections and Infestations Malaria
Conditions
Interventions
Combination antimalarial therapy versus established monotherapy. Single-blind open-label randomised controlled trial run over three consecutive transmission seasons in Farafenni, The Gambia.
Sponsors
London School of Hygiene and Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children one to ten years of age (either sex) attending Farafenni Health Centre, The Gambia, from September to December in each of 2000, 2001 and 2002 2. Children with a temperature more than 37.5°C, or a history of fever 3. Blood-film positive for P. falciparum at a density greater than 500 parasites per ml 4. Signed informed consent was obtained
Exclusion criteria
Exclusion criteria: 1. An inability to take drugs orally 2. Treatment with antimalarial chemotherapy within the past two weeks 3. Carriage of circulating gametocytes at presentation 4. Any evidence of chronic disease or acute infection other than malaria 5. Domicile outside the study area (approximately 10 km radius) 6. Any signs or symptoms of severe malaria: 6.1. Severe anaemia (peripheral blood Packed Cell Volume [PCV] less than 20%) 6.2. Hyper-parasitaemia (more than 250,000 per ml peripheral blood) 6.3. Respiratory distress (respiratory rate more than 40 with two of the following: nasal flaring, intercostal indrawing, subcostal recession or grunting) 6.4. Repeated generalised convulsions (three or more per 24 hours or two witnessed seizures in 24 hours) 6.5. Haemoglobinuria (dark red/black urine) 6.6. Jaundice 6.7. Prostration 6.8. Circulatory collapse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major endpoints were: 1. Post-treatment gametocyte carriage over 28 days 2. Infectiousness to mosquitoes of children carrying gametocytes seven days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Minor endpoints were: 1. Clinical and parasitological drug efficacy over 28 days of follow-up | — |
Countries
Gambia
Outcome results
None listed