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

Sponsors and Collaborators:	London School of Hygiene and Tropical Medicine Medical Research Council National Malaria Control Programme, The Gambia
Information provided by:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00118807

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 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine diphosphate Chloroquine Pyrimethamine Fansidar Artesunate Amodiaquine Sulfadoxine Chloroquine hydrochloride Amodiaquine hydrochloride

U.S. FDA Resources

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

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

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

Keywords provided by London School of Hygiene and Tropical Medicine:

malaria treatment
artemisinin based combination therapy
Plasmodium falciparum
pragmatic trial
effectiveness

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 09, 2009