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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118807
• Other study ID #: SCC940
• Secondary ID: MRC SCC No. 940
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2005
• Last updated: January 6, 2006
• Start date: August 2003
• Est. completion date: February 2004

Study information

• Verified date: June 2003
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: Department of State for Health and Social Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Amodiaquine plus artesunate (AQ/AS)

• Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)

• Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)

Locations

Country	Name	City	State
Gambia	Medical Research Council Laboratories	Banjul

Sponsors (3)

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

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical failure by day 28
Primary	Incidence of adverse events
Secondary	Compliance with treatment regimen
Secondary	Parasitological failure by day 28
Secondary	Clinical failure by day 14
Secondary	Parasitological failure rate by day 14
Secondary	Mean PCV on day 28
Secondary	Gametocyte carriage rates
Secondary	Transmissibility after treatment