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ACT for the Home Management in Malagasy Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612547
First Posted: February 11, 2008
Last Update Posted: February 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Population Services International
Reggio Terzo Mondo
Santé Net
Inter Aide Santé,
Adventist Development and Relief Agency
SAF FJKM
Sanofi
Institut Pasteur de Madagascar
Information provided by:
National Malaria Control Programme, Madagascar
  Purpose
The purpose of this study is to assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers.

Condition Intervention
Fever Suspected Malaria Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children

Resource links provided by NLM:


Further study details as provided by National Malaria Control Programme, Madagascar:

Primary Outcome Measures:
  • Assessment of the councils delivered by the community-based service provider to the parents or guardians of children and assessment of the observance of the treatment given by the parents or guardians. [ Time Frame: one year ]

Secondary Outcome Measures:
  • To assess the Artesunate + Amodiaquine Fixed Dose Combination in term of effectiveness, tolerance, safety:; the reliability of the RDT; the real burden of the malaria in children under the age of five years in 2 different epidemiological strata. [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 1200
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation
Children under the age of five years (2 months to 5 years) residing in the zone covered by the community-based service provider throughout the entire follow-up period
Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)

Tablet:

Children aged between 2 and 11 months: Artesunate 25 mg + Amodiaquine 67.5 mg et Children aged between 12 and 59 months: Artesunate 50 mg + Amodiaquine 135 mg Per os one intake per day/3 day


Detailed Description:

Primary objective

To assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers

Secondary objectives

To assess the reliability of the use of the malaria rapid diagnostic tests (RDT) by the community-based service providers in the Malagasy home management strategy

To assess the frequency of short-term and long-term side effects of the Artesunate + Amodiaquine Fixed Dose Combination used for the home management of presumed malaria in Malagasy children by the community-based service providers

To assess the real burden of the malaria in children under the age of five years in 2 different epidemiological strata of Madagascar (central highlands and equatorial strata)

Type of study

Follow-up of a cohort of 1200 children under the age of five years during 1 year

Studied population

All children under the age of five years (2 months to 5 years) having fever and consulting the community-based service provider, residing in the zone covered by the community-based service provider throughout the entire follow-up period Investigators Four community-based service providers, four field physicians and two supervisors number of district: 2 (Moramanga and Manakara)

condition: fever intervention: artesunate + amodiaquine phase: phase IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • All children under the age of five years (2 months to 5 years) having fever and consulting the community-based service provider, residing in the zone covered by the community-based service provider throughout the entire follow-up period, having signed an informed consent

Exclusion Criteria:

  • Children with no informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612547


Locations
France
Institut Pasteur
Paris, France, 75724
Sponsors and Collaborators
National Malaria Control Programme, Madagascar
Population Services International
Reggio Terzo Mondo
Santé Net
Inter Aide Santé,
Adventist Development and Relief Agency
SAF FJKM
Sanofi
Institut Pasteur de Madagascar
Investigators
Study Chair: Benjamin Ramarosandratana, MD National Malaria Control Programme
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Didier Ménard, Head of the Malaria Research Unit, Institut Pasteur de Madagascar
ClinicalTrials.gov Identifier: NCT00612547     History of Changes
Other Study ID Numbers: ACTComMada
First Submitted: January 28, 2008
First Posted: February 11, 2008
Last Update Posted: February 26, 2009
Last Verified: February 2009

Keywords provided by National Malaria Control Programme, Madagascar:
Protozoan Infections
Communicable Diseases
Malaria Infection
Malaria, falciparum
Malaria, vivax
Artesunate Amodiaquine

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Amodiaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials