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
  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
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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
effectiveness

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Chloroquine
Chloroquine diphosphate
Sulfadoxine
Amodiaquine
Pyrimethamine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Anti-Infective Agents, Urinary

ClinicalTrials.gov processed this record on September 18, 2014