Children's Antibiotic Resistant Infections in Low Income Countries

• Conditions: Bacterial Infections
• Interventions: Biological: biological samples

• Registration Number: NCT02074865
• Lead Sponsor: Institut Pasteur

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-07-10
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-25
• Last Update Submitted: 2014-02-25
• Study First Posted: 2014-02-28
• Last Update Posted: 2014-02-28
• Primary Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
newborns	biological samples	-

Primary Outcome Measures

Name	Time	Method
Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).	27 months

Secondary Outcome Measures

Name	Time	Method
Bacterial aetiology of neonatal infection in low income countries and its resistance	27 months
Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries	27 months

Trial Locations

Locations (1)

institut pasteur in Madagascar; 🇲🇬 Antananarivo, Madagascar