ACT for the Home Management in Malagasy Children

Fever Clinical Trial

Official title:

Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612547
• Other study ID #: ACTComMada
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: February 25, 2009
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: National Malaria Control Programme, Madagascar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Madagascar: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 5 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fever
• Malaria
• Suspected Malaria

Intervention

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

Locations

Country	Name	City	State
France	Institut Pasteur	Paris

Sponsors (9)

Lead Sponsor	Collaborator
National Malaria Control Programme, Madagascar	Adventist Development and Relief Agency, Institut Pasteur de Madagascar, Inter Aide Santé,, Population Services International, Reggio Terzo Mondo, SAF FJKM, Sanofi, Santé Net

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No