Clinical trial NCT00612547: ACT for the Home Management in Malagasy Children
Official title: Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Suspected Malaria
Keywords: Protozoan Infections
Communicable Diseases
Malaria Infection
Malaria, falciparum
Malaria, vivax
Artesunate Amodiaquine
Lead sponsor: National Malaria Control Programme, Madagascar
Sponsor class: OTHER_GOV
Collaborators: name: Population Services International
name: Reggio Terzo Mondo
name: Santé Net
name: Inter Aide Santé,
name: Adventist Development and Relief Agency
name: SAF FJKM
name: Sanofi
name: Institut Pasteur de Madagascar
First posted: 2008-02-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: one year
Secondary outcomes:
measure: 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.
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Pasteur
Study officials:
affiliation: National Malaria Control Programme
name: Benjamin Ramarosandratana, MD
role: STUDY_CHAIR
References:
citation: Ratsimbasoa A, Ravony H, Vonimpaisomihanta JA, Raherinjafy R, Jahevitra M, Rapelanoro R, Rakotomanga Jde D, Malvy D, Millet P, Menard 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. doi: 10.1186/1475-2875-11-85.