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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Medical Research Council National Malaria Control Programme, The Gambia |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00118807 |
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 |
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Malaria |
Drug: Amodiaquine plus artesunate (AQ/AS) Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 1800 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | February 2004 |
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:
Exclusion Criteria:
Gambia | |
Medical Research Council Laboratories | |
Banjul, Gambia, POBOX273 |
Principal Investigator: | Sam K Dunyo, PhD | Medical Research Council |
Principal Investigator: | Paul J Milligan, PhD | London School of Hygiene and Tropical Medicine |
Study ID Numbers: | SCC940, MRC SCC No. 940 |
Study First Received: | July 1, 2005 |
Last Updated: | January 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00118807 History of Changes |
Health Authority: | Gambia: Department of State for Health and Social Welfare |
malaria treatment artemisinin based combination therapy Plasmodium falciparum pragmatic trial effectiveness |
Pyrimethamine Anti-Inflammatory Agents Anti-Infective Agents Artemisinine Folate Malaria Vitamin B9 Antimalarials Artemisinins Parasitic Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Artesunate Protozoan Infections |
Amodiaquine Sulfadoxine-pyrimethamine Chloroquine Anthelmintics Anti-Infective Agents, Urinary Sulfadoxine Folic Acid Antagonists Folinic Acid Folic Acid Analgesics, Non-Narcotic Chloroquine diphosphate Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Pyrimethamine Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Malaria Renal Agents Antimalarials Antiparasitic Agents Sensory System Agents Therapeutic Uses Parasitic Diseases Anti-Inflammatory Agents, Non-Steroidal Amebicides |
Analgesics Antinematodal Agents Artesunate Protozoan Infections Sulfadoxine-pyrimethamine Amodiaquine Filaricides Coccidiosis Chloroquine Anti-Infective Agents, Urinary Enzyme Inhibitors Anthelmintics Folic Acid Antagonists Sulfadoxine Pharmacologic Actions |