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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118807
First Posted: July 12, 2005
Last Update Posted: January 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council
National Malaria Control Programme, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine
  Purpose
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
Malaria 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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118807


Locations
Gambia
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
  More Information

ClinicalTrials.gov Identifier: NCT00118807     History of Changes
Other Study ID Numbers: SCC940
MRC SCC No. 940
First Submitted: July 1, 2005
First Posted: July 12, 2005
Last Update Posted: January 9, 2006
Last Verified: June 2003

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

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
Amodiaquine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary