Children's Antibiotic Resistant Infections in Low Income Countries

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02074865
• Date of registration: 10/07/2013
• Prospective Registration: No
• Primary sponsor: Institut Pasteur
• Public title: Children's Antibiotic Resistant Infections in Low Income Countries ChARLI
• Scientific title: Children's Antibiotic Resistant Infections in Low Income Countries
• Date of first enrolment: September 2012
• Target sample size: 1000
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02074865
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Madagascar

Contacts

• Name: Didier Guillemot, MD, PhD

• Name: Benoit Garin, MD

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: 3 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Bacterial Infections

Intervention(s)

Biological: biological samples

Primary Outcome(s)

Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age). [Time Frame: 27 months]

Secondary Outcome(s)

Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries [Time Frame: 27 months]

Bacterial aetiology of neonatal infection in low income countries and its resistance [Time Frame: 27 months]

Secondary ID(s)

2012-11 ChARLI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

department of International cooperation of Monaco (funding)

Institut Pasteur in Madagascar (subject recruitment)