Clinical trial NCT02074865: Children's Antibiotic Resistant Infections in Low Income Countries
Official title: Children's Antibiotic Resistant Infections in Low Income Countries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infections
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur in Madagascar (subject recruitment)
name: department of International cooperation of Monaco (funding)
First posted: 2014-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newborns

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


Eligibility 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.

Primary outcomes:
measure: Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).
timeFrame: 27 months
Secondary outcomes:
measure: Bacterial aetiology of neonatal infection in low income countries and its resistance
timeFrame: 27 months
measure: Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries
timeFrame: 27 months
Other outcomes:
Locations:
city: Antananarivo
country: Madagascar
facility: institut pasteur in Madagascar
Study officials:
References: