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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
History of Changes

January 28, 2008
February 25, 2009
February 2008
February 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00612547 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
ACT for the Home Management in Malagasy Children
Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood
Non-Probability Sample

community sample
  • Fever
  • Suspected Malaria
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
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
Intervention: Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)
Ratsimbasoa A, Ravony H, Vonimpaisomihanta JA, Raherinjafy R, Jahevitra M, Rapelanoro R, Rakotomanga Jde D, Malvy D, Millet P, Ménard D. Management of uncomplicated malaria in febrile under five-year-old children by community health workers in Madagascar: reliability of malaria rapid diagnostic tests. Malar J. 2012 Mar 25;11:85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
2 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00612547
ACTComMada
No
Didier Ménard, Head of the Malaria Research Unit, Institut Pasteur de Madagascar
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
Study Chair: Benjamin Ramarosandratana, MD National Malaria Control Programme
National Malaria Control Programme, Madagascar
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP