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

London School of Hygiene and Tropical Medicine1,800 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,800

Conditions

Malaria

Interventions

Amodiaquine plus artesunate (AQ/AS)DRUG

Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)DRUG

Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)DRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Research Council Laboratories

Banjul, City of Banjul, The Gambia

Outcomes

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

Data from ClinicalTrials.gov

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