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

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00118807

Collaborator

Medical Research Council (Other), National Malaria Control Programme, The Gambia (Other)

1,800

Enrollment

Location

Duration (Months)

297.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Amodiaquine plus artesunate (AQ/AS) Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children

Study Start Date :

Aug 1, 2003

Study Completion Date :

Feb 1, 2004

Outcome Measures

Primary Outcome Measures

Clinical failure by day 28 []
Incidence of adverse events []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 10 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Council Laboratories	Banjul		Gambia	POBOX273

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine
Medical Research Council
National Malaria Control Programme, The Gambia

Investigators

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