Trials / Completed
CompletedNCT00118807
Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children
Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,800 (planned)
- Sponsor
- London School of Hygiene and Tropical Medicine · Academic / Other
- Sex
- All
- Age
- 6 Months – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amodiaquine plus artesunate (AQ/AS) | |
| DRUG | Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) | |
| DRUG | Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ) |
Timeline
- Start date
- 2003-08-01
- Completion
- 2004-02-01
- First posted
- 2005-07-12
- Last updated
- 2006-01-09
Locations
1 site across 1 country: The Gambia
Source: ClinicalTrials.gov record NCT00118807. Inclusion in this directory is not an endorsement.