FeverNCT00612547
ACT for the Home Management in Malagasy Children
An observational study of Fever and Suspected Malaria, run by National Malaria Control Programme, Madagascar at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Fever, Suspected Malaria
- What is being tested?
- Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: community sample
Who may be able to join
- 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
Who cannot join
- Children with no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children
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.
Read the 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
- Conditions
- Fever, Suspected Malaria
- Being tested
- Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)
- Keywords
- Protozoan Infections, Communicable Diseases, Malaria Infection, Malaria, falciparum, Malaria, vivax, Artesunate Amodiaquine
- Medical subject headings
- Fever, Protozoan Infections, Communicable Diseases, Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Malaria Control Programme, Madagascar
- Sponsor type
- Other government
- Collaborators
- Population Services International, Reggio Terzo Mondo, Santé Net, Inter Aide Santé,, Adventist Development and Relief Agency, SAF FJKM, Sanofi, Institut Pasteur de Madagascar
- Investigators
- Benjamin Ramarosandratana, MD, Study chair, National Malaria Control Programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612547
- Sponsor's protocol ID
- ACTComMada
- Status last verified
- Feb 2009
- First submitted
- 28 Jan 2008
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22443344
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children
- ClinicalTrials.gov ID
- NCT00612547
- Acronym / sponsor ID
- ACTComMada
- Conditions
- Fever, Suspected Malaria
- Keywords
- Protozoan Infections, Communicable Diseases, Malaria Infection, Malaria, falciparum, Malaria, vivax, Artesunate Amodiaquine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- National Malaria Control Programme, MadagascarOther government
- Collaborators
- Population Services International, Reggio Terzo Mondo, Santé Net, Inter Aide Santé,, Adventist Development and Relief Agency, SAF FJKM, Sanofi, Institut Pasteur de Madagascar
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Drug: Artesunate + Amodiaquine Fixed Dose Combination (CoArsucam)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 |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- community sample
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children with no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Observation |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
- Derived from this study: PubMed 22443344Ratsimbasoa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Ramarosandratana, MD study chair
National Malaria Control Programme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Suspected Malaria, run by National Malaria Control Programme, Madagascar at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00612547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2009.