Trial | NCT00118807  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1800
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.
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.
Study Started
Aug 31
2003
Study Completion
Feb 29
2004
Last Update
Jan 09
2006
Estimate

Drug Amodiaquine plus artesunate (AQ/AS)

Drug Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)

Drug Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)

Criteria 

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
No Results Posted