Skip to main content
OpenTrials
Completed

NCT Number: NCT00612547

ACT for the Home Management 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Malaria Control Programme, Madagascar

Other Gov

Collaborators

  • Adventist Development and Relief Agency
  • Institut Pasteur de Madagascar
  • Inter Aide Santé,
  • Population Services International
  • Reggio Terzo Mondo
  • SAF FJKM
  • Sanofi
  • Santé Net

Registry information

Official study title

Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2008
Registry last updated
Feb 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.