Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children

London School of Hygiene and Tropical Medicine

Status and phase

Completed

Phase 3

Conditions

Malaria

Treatments

Drug: Amodiaquine plus artesunate (AQ/AS)

Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)

Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)

Study type

Interventional

Funder types

Other

Identifiers

NCT00118807

SCC940

MRC SCC No. 940

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

6 months to 10 years old

Volunteers

No Healthy Volunteers

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