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

This study has been completed.
Medical Research Council
National Malaria Control Programme, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine Identifier:
First received: July 1, 2005
Last updated: January 6, 2006
Last verified: June 2003
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 Intervention Phase
Drug: Amodiaquine plus artesunate (AQ/AS)
Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)
Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

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

Estimated Enrollment: 1800
Study Start Date: August 2003
Estimated Study Completion Date: February 2004
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.

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00118807

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
Principal Investigator: Sam K Dunyo, PhD Medical Research Council
Principal Investigator: Paul J Milligan, PhD London School of Hygiene and Tropical Medicine
  More Information Identifier: NCT00118807     History of Changes
Other Study ID Numbers: SCC940  MRC SCC No. 940 
Study First Received: July 1, 2005
Last Updated: January 6, 2006
Health Authority: Gambia: Department of State for Health and Social Welfare

Keywords provided by London School of Hygiene and Tropical Medicine:
malaria treatment
artemisinin based combination therapy
Plasmodium falciparum
pragmatic trial

Additional relevant MeSH terms:
Parasitic Diseases
Protozoan Infections
Chloroquine diphosphate
Fanasil, pyrimethamine drug combination
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Infective Agents, Urinary
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antinematodal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Renal Agents processed this record on May 26, 2016