ACT for the Home Management in Malagasy Children

National Malaria Control Programme, Madagascar

Status: Completed

Conditions: Fever; Suspected Malaria

Treatments: Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00612547

ACTComMada

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,200 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Observation

Description:

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

Treatment:

Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)