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

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
National Malaria Control Programme, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00118807
First received: July 1, 2005
Last updated: January 6, 2006
Last verified: June 2003

July 1, 2005
January 6, 2006
August 2003
Not Provided
  • Clinical failure by day 28
  • Incidence of adverse events
Same as current
Complete list of historical versions of study NCT00118807 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children
Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
  • Drug: Amodiaquine plus artesunate (AQ/AS)
  • Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)
  • Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
February 2004
Not Provided

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
Both
6 Months to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Gambia
 
NCT00118807
SCC940, MRC SCC No. 940
Not Provided
Not Provided
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
London School of Hygiene and Tropical Medicine
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP