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| Sponsors and Collaborators: |
National Malaria Control Programme, Madagascar Population Service International Reggio Terzo Mondo Santé Net Inter Aide Santé, Adventist Development and Relief Agency SAF FJKM Sanofi-Aventis Institut Pasteur de Madagascar |
| Information provided by: | National Malaria Control Programme, Madagascar |
| ClinicalTrials.gov Identifier: | NCT00612547 |
Purpose
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.
| Condition | Intervention |
|
Fever Suspected Malaria |
Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam) |
| MedlinePlus related topics: | Fever Malaria |
| Drug Information available for: | Artesunate Amodiaquine Amodiaquine hydrochloride |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children |
Whole blood
| Estimated Enrollment: | 1200 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|
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 |
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
| Ages Eligible for Study: | 2 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
community sample
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Didier Ménard, Pharm, PhD | (261) 20 22 412 72 | dmenard@pasteur.mg |
| Contact: Arsène ratsimbasoa, MD | (261) 20 22 412 72 | arsene@pasteur.mg |
| Madagascar | |||||
| Institut Pasteur de Madagascar | Recruiting | ||||
| Antananarivo, Madagascar, 101 | |||||
| Contact: Didier Ménard, Pharm, PhD (261) 20 22 412 72 dmenard@pasteur.mg | |||||
| Contact: Arsène Ratsimbasoa, MD (261) 20 22 412 72 arsene@pasteur.mg | |||||
| Principal Investigator: Didier Ménard, Pharm, PhD | |||||
| National Malaria Control Programme, Madagascar |
| Population Service International |
| Reggio Terzo Mondo |
| Santé Net |
| Inter Aide Santé, |
| Adventist Development and Relief Agency |
| SAF FJKM |
| Sanofi-Aventis |
| Institut Pasteur de Madagascar |
| Study Chair: | Benjamin Ramarosandratana, MD | National Malaria Control Programme |
More Information
| Responsible Party: | Institut Pasteur de Madagascar ( Didier Ménard, Head of the Malaria Research Unit ) |
| Study ID Numbers: | ACTComMada |
| First Received: | January 28, 2008 |
| Last Updated: | October 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00612547 |
| Health Authority: | Madagascar: Ministry of Health |
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