ACT for the Home Management in Malagasy Children
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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) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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 |
- 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. [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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. [ Time Frame: one year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood
| Enrollment: | 1200 |
| Study Start Date: | February 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 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 |
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| 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:
- 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
Contacts and Locations| France | |
| Institut Pasteur | |
| Paris, France, 75724 | |
| Study Chair: | Benjamin Ramarosandratana, MD | National Malaria Control Programme |
More Information
No publications provided by National Malaria Control Programme, Madagascar
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Didier Ménard, Head of the Malaria Research Unit, Institut Pasteur de Madagascar |
| ClinicalTrials.gov Identifier: | NCT00612547 History of Changes |
| Other Study ID Numbers: | ACTComMada |
| Study First Received: | January 28, 2008 |
| Last Updated: | February 25, 2009 |
| Health Authority: | Madagascar: Ministry of Health |
Keywords provided by National Malaria Control Programme, Madagascar:
|
Protozoan Infections Communicable Diseases Malaria Infection |
Malaria, falciparum Malaria, vivax Artesunate Amodiaquine |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Amodiaquine Artesunate Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Amebicides |
ClinicalTrials.gov processed this record on May 19, 2013