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.

Condition	Intervention	Phase
Malaria	Drug: Amodiaquine plus artesunate (AQ/AS)  Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)  Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)	Phase III

Further Study Details: 

Primary Outcomes: Clinical failure by day 28; Incidence of adverse events
Secondary Outcomes: Compliance with treatment regimen; Parasitological failure by day 28; Clinical failure by day 14; Parasitological failure rate by day 14; Mean PCV on day 28; Gametocyte carriage rates; Transmissibility after treatment
Expected Total Enrollment:  1800

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.

Ages Eligible for Study:  6 Months   -   10 Years,  Genders Eligible for Study:  Both

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

Gambia
      Medical Research Council Laboratories, BANJUL,  POBOX273,  Gambia

Study chairs or principal investigators

Sam K Dunyo, PhD,  Principal Investigator,  Medical Research Council Laboratories   
Paul J Milligan, PhD,  Principal Investigator,  London School of Hygiene and Tropical Medicine   

Study ID Numbers:  SCC940; MRC SCC No. 940
Last Updated:  July 18, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118807
Health Authority: Gambia: Department of State for Health and Social Welfare
ClinicalTrials.gov processed this record on 2005-08-02