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

Phase 3

Completed

• Conditions: Malaria

• Registration Number: NCT00118807
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

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 Timeline

• Status Verified: 2003-06
• Study Start: 2003-08
• Study Completion: 2004-02
• Study First Submitted: 2005-07-01
• Study First Submitted QC: 2005-07-01
• Study First Posted: 2005-07-12
• Last Update Submitted: 2006-01-06
• Last Update Posted: 2006-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical failure by day 28
Incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Research Council Laboratories; 🇬🇲 Banjul, Gambia