NCT00612547

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

January 28, 2008

Last Update Submit

February 25, 2009

Conditions

FeverSuspected Malaria

Keywords

Protozoan InfectionsCommunicable DiseasesMalaria InfectionMalaria, falciparumMalaria, vivaxArtesunate Amodiaquine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

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)

Interventions

Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)DRUG

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

Observation

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • 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

You may not qualify if:

  • Children with no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur

Paris, 75724, France

Location

Related Publications (1)

  • 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.

    PMID: 22443344DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

FeverProtozoan InfectionsCommunicable DiseasesMalaria, FalciparumMalaria, Vivax

Interventions

ArtesunateAmodiaquine

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsParasitic DiseasesInfectionsDisease AttributesPathologic ProcessesMalariaMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Benjamin Ramarosandratana, MD

    National Malaria Control Programme

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

FR(1)