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

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.

Study Overview

• Status: Completed
• Conditions: Fever; Suspected Malaria
• Intervention / Treatment: Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)

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 Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• France
  • Paris, France, 75724
    • Institut Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Malaria Control Programme, Madagascar
• Collaborators: Sanofi; Population Services International; Institut Pasteur de Madagascar; Reggio Terzo Mondo; Santé Net; Inter Aide Santé,; Adventist Development and Relief Agency; SAF FJKM
• Investigators: Study Chair: Benjamin Ramarosandratana, MD, National Malaria Control Programme

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: January 28, 2008
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2009
• Last Update Submitted That Met QC Criteria: February 25, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Protozoan Infections; Communicable Diseases; Malaria Infection; Malaria, falciparum; Malaria, vivax; Artesunate Amodiaquine
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Artesunate; Amodiaquine
• Other Study ID Numbers: ACTComMada