ACT for the Home Management in Malagasy Children

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00612547
First received: January 28, 2008
Last updated: February 25, 2009
Last verified: February 2009
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Months to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by National Malaria Control Programme, Madagascar

Additional 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
Study First Received: January 28, 2008
Last Updated: February 25, 2009
Health Authority: Madagascar: Ministry of Health

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
Amodiaquine
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on April 21, 2014