Children's Antibiotic Resistant Infections in Low Income Countries
ChARLI
1 other identifier
observational
1,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedFebruary 28, 2014
February 1, 2014
1.5 years
July 10, 2013
February 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).
27 months
Secondary Outcomes (2)
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
Study Arms (1)
newborns
Interventions
Eligibility Criteria
newborns
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
institut pasteur in Madagascar
Antananarivo, Madagascar
Related Links
Biospecimen
At birth, for therapeutic management of the newborns in the presence of a risk factor for infection :gastric fluid, external auditory canal swabs, anal swabs, placental biopsy. Before empirical antibiotic treatment: blood cultures, blood sampling for CRP determination.In the presence of particular warning signs of infection chest X ray and lumbar puncture. During the follow-up, for therapeutic management of the newborns if the child has a suspected infection : urine samples, blood for blood cultures and Blood formula and C-reactive protein (CRP) detrmination; rhinopharyngeal fluid samples, lumbar puncture in febrile children under the age of three months; and thick blood smears if the child has a fever. Samples based on the presence of particular warning signs of infection: stool samples, eye or ear swabbing, chest X
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2013
First Posted
February 28, 2014
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Last Updated
February 28, 2014
Record last verified: 2014-02