A Trial of Four Drug Regimens for the Prevention of Malaria in Senegalese Children

This study has been completed.

First Received on August 18, 2005. Last Updated on October 14, 2005 History of Changes

Sponsor:	Gates Malaria Partnership
Collaborators:	Institut de Recherche pour le Developpement, Senegal Cheikh Anta Diop University, Senegal Ministry of Health, Senegal
Information provided by:	Gates Malaria Partnership
ClinicalTrials.gov Identifier:	NCT00132548

Purpose

A recent study has shown that the administration of a single dose of sulfadoxine/pyrimethamine plus artesunate to Senegalese children on three occasions during a short malaria transmission season reduced the incidence of clinical attacks of malaria by 86%. However, use of this drug regimen led to the selection of parasites with molecular markers of resistance to pyrimethamine and sulfadoxine. Therefore, a trial of three alternative regimens has been undertaken to see if these are as effective and safe as the drug combination used in the initial study but less likely to select for drug resistance.

Condition	Intervention	Phase
Malaria	Drug: Pyrimethamine/sulfadoxine Drug: Amodiaquine Drug: Artesunate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	A Randomised Trial of the Efficacy and Safety of Four Drug Regimens When Used for Intermittent Preventive Treatment of Malaria in Senegalese Children

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Artesunate Amodiaquine Sulfadoxine Amodiaquine hydrochloride

U.S. FDA Resources

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:

Prevalence of drug resistance

Secondary Outcome Measures:

Incidence of clinical malaria
Side effects

Estimated Enrollment:	2200
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 1 - 5 years
Residence in the study area
Informed consent

Exclusion Criteria:

Known allergy to study drugs
Chronic, underlying illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132548

Locations

Senegal
Institut de recherche pour le developpement
Dakar, Senegal, BP 1386

Sponsors and Collaborators

Gates Malaria Partnership

Institut de Recherche pour le Developpement, Senegal

Cheikh Anta Diop University, Senegal

Ministry of Health, Senegal

Investigators

Principal Investigator:

Cheick Sokhna, PhD

Institut de Recherche pour le Developpement, Senegal

More Information

Additional Information:

web site for the IPTi consortium This link exits the ClinicalTrials.gov site

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sokhna C, Cissé B, Bâ el H, Milligan P, Hallett R, Sutherland C, Gaye O, Boulanger D, Simondon K, Simondon F, Targett G, Lines J, Greenwood B, Trape JF. A trial of the efficacy, safety and impact on drug resistance of four drug regimens for seasonal intermittent preventive treatment for malaria in Senegalese children. PLoS ONE. 2008 Jan 23;3(1):e1471.

ClinicalTrials.gov Identifier:	NCT00132548 History of Changes
Other Study ID Numbers:	ITCRVF02
Study First Received:	August 18, 2005
Last Updated:	October 14, 2005
Health Authority:	Senegal: Ministere de la sante

Keywords provided by Gates Malaria Partnership:

Malaria
Children
Intermittent preventive treatment
Senegal

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents

Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on February 09, 2012