ACT for the Home Management in Malagasy Children

Completed

• Conditions: Fever; Suspected Malaria
• Interventions: Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)

• Registration Number: NCT00612547
• Lead Sponsor: National Malaria Control Programme, Madagascar

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study Start: 2008-02
• Study First Posted: 2008-02-11
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-25
• Last Update Posted: 2009-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation	Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)	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

Primary Outcome Measures

Name	Time	Method
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.	one year

Secondary Outcome Measures

Name	Time	Method
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.	one year

Trial Locations

Locations (1)

Institut Pasteur; 🇫🇷 Paris, France