Children's Antibiotic Resistant Infections in Low Income Countries

Bacterial Infections Clinical Trial

— ChARLI  

Official title:

Children's Antibiotic Resistant Infections in Low Income Countries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02074865
• Other study ID #: 2012-11 ChARLI
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2013
• Last updated: February 25, 2014
• Start date: September 2012

Study information

• Verified date: February 2014
• Source: Institut Pasteur
• Contact: Didier Guillemot, MD, PhD
• Phone: 0145688301
• Email: didier.guillemot[@]pasteur.fr
• Is FDA regulated: No
• Health authority: Madagascar: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Infection

Intervention

Biological:
• biological samples

Locations

Country	Name	City	State
Madagascar	institut pasteur in Madagascar	Antananarivo

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur	department of International cooperation of Monaco (funding), Institut Pasteur in Madagascar (subject recruitment)

Country where clinical trial is conducted

Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).		27 months	No
Secondary	Bacterial aetiology of neonatal infection in low income countries and its resistance		27 months	No
Secondary	Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries		27 months	No

External Links

•   Link