Malaria
Conditions
Keywords
malaria treatment, artemisinin based combination therapy, Plasmodium falciparum, pragmatic trial, effectiveness
Brief summary
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
Detailed description
Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.
Interventions
DRUGAmodiaquine plus artesunate (AQ/AS)
DRUGSulfadoxine-pyrimethamine plus chloroquine (SP/CQ)
DRUGSulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)
Sponsors
Medical Research Council
National Malaria Control Programme, The Gambia
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
* Presentation at health centre with febrile illness * Monoinfection with P. falciparum * Parasitaemia \>=500/microlitre * Fever or history of fever
Exclusion criteria
* Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia \>200,000/ul) * Severe malnutrition * Clinically evident concomitant disease * PCV \<20% * History of allergy to the study medications * Residence outside the study area and hence difficult to follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical failure by day 28 | — |
| Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical failure by day 14 | — |
| Parasitological failure rate by day 14 | — |
| Compliance with treatment regimen | — |
| Gametocyte carriage rates | — |
| Transmissibility after treatment | — |
| Mean PCV on day 28 | — |
| Parasitological failure by day 28 | — |
Countries
The Gambia
Outcome results
None listed