NCT00612547

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: National Malaria Control Programme, Madagascar · Other Government
• Sex: All
• Age: 2 Months – 5 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fever
• Suspected Malaria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-11
• Last updated: 2009-02-26

Locations

1 site across 1 country: France