Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2008-02-29
2009-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Months
5 Years
ALL
No
Sponsors
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Population Services International
OTHER
Reggio Terzo Mondo
UNKNOWN
Santé Net
UNKNOWN
Inter Aide Santé,
UNKNOWN
Adventist Development and Relief Agency
OTHER
SAF FJKM
UNKNOWN
Sanofi
INDUSTRY
Institut Pasteur de Madagascar
OTHER
National Malaria Control Programme, Madagascar
OTHER_GOV
Responsible Party
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Institut Pasteur de Madagascar
Principal Investigators
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Benjamin Ramarosandratana, MD
Role: STUDY_CHAIR
National Malaria Control Programme
Locations
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Institut Pasteur
Paris, , France
Countries
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References
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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.
Other Identifiers
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ACTComMada
Identifier Type: -
Identifier Source: org_study_id