ClinicalTrials.gg
Status unknownNCT02074865ChARLIUpdated Feb 28, 2014

Children's Antibiotic Resistant Infections in Low Income Countries

An observational study in Bacterial Infections, sponsored by Institut Pasteur. Status unknown at 1 site in Madagascar. Open to participants aged 1 Minute to 3 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-28.

Sponsored by Institut Pasteur · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
1 Minute to 3 Days
Sex
All
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Study 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

02

Conditions studied

  • Bacterial Infections

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03

In context

Bacterial Infections

584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 185 observational studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 3 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

newborns

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • newborns

    Biological: biological samples

Interventions

  • Biologicalbiological samples
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What researchers measure

Primary outcomes

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

    Time frame: 27 months

Secondary outcomes

  1. Bacterial aetiology of neonatal infection in low income countries and its resistance

    Time frame: 27 months

  2. Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries

    Time frame: 27 months

07

Study locations

1 of 1 sites recruiting
  • institut pasteur in Madagascar
    Antananarivo, Madagascar
    Recruiting
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References and documents

Related links

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012 and a primary completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2013
First posted
Feb 28, 2014
Start
Sep 2012
Primary completionEst.
Mar 2014
Last update
Feb 28, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02074865
Lead sponsor
Institut Pasteur
Collaborators
Institut Pasteur in Madagascar (subject recruitment), department of International cooperation of Monaco (funding)
Responsible party
Sponsor
First posted
Feb 28, 2014
Start date
Sep 2012
Primary completion
Mar 2014 (estimated)
Last update
Feb 28, 2014

Study contacts

Didier Guillemot, MD, PhD
Contact
didier.guillemot@pasteur.fr
0145688301

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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