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Children's Antibiotic Resistant Infections in Low Income Countries

NCT ID: NCT02074865

Last Updated: 2014-02-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Brief Summary

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The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal and childhood bacterial infections in low-income countries,in particular those caused by antibiotic resistant bacteria. This program will address both healthcare associated, as well as community acquired infections. Beside its main challenge, the ChARLI program will also allow the assessment of the economic burden of these infections, the improvement of their medical care and then ultimately help to set public health interventions and guide public health measures necessary to combat bacterial infections and bacterial resistance in children. It will also lead to set up more basic research investigation to better understand how pathogenic and epidemic may be the resistant clones in these countries and to experiment innovative strategies devoted to prevent these infections.

In order to achieve these objectives, an international paediatric cohort will be created, and monitored a platform. This will be done first within the Institut Pasteur International Network (IPIN) and possibly extended in some others low income countries where the IPIN has no center. This constituted initiative will represent the first international pediatric program of its size to be located in low-income countries and specifically focusing severe bacterial infections and bacterial resistance to antibiotics

Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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newborns

biological samples

Intervention Type BIOLOGICAL

Interventions

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biological samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Neonate born to parents living in the study zone of a participating country
* Parents of the neonate not intending to move away from the study zone during the follow-up period
* Legal guardians of the neonate informed about the way in which the study is to be carried out and about the collection of biological samples
* Legal guardians of the neonate having no objection to the collection of biological samples
* Authorisation from at least one of the legal guardians of the child, in the form of a signed informed consent form.

Exclusion Criteria

* Stillborn neonate
* Parents of the neonate living outside the study zone of a participating country
* Neonate born to parents planning to move away from the study zone of a participating country during the follow-up period
* At least one of the legal guardians of the neonate not informed about the study or about the collection of biological samples
* At least one of the legal guardians of the neonate opposed to the collection of biological samples.
* Neonate already participating in another biomedical study.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur in Madagascar (subject recruitment)

UNKNOWN

Sponsor Role collaborator

department of International cooperation of Monaco (funding)

UNKNOWN

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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institut pasteur in Madagascar

Antananarivo, , Madagascar

Site Status RECRUITING

Countries

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Madagascar

Central Contacts

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Didier Guillemot, MD, PhD

Role: CONTACT

Phone: 0145688301

Email: [email protected]

Facility Contacts

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Benoit Garin, MD

Role: primary

Related Links

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http://www.charliproject.org/

Related Info

Other Identifiers

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2012-11 ChARLI

Identifier Type: -

Identifier Source: org_study_id