Bacterial InfectionsChARLINCT02074865
Children's Antibiotic Resistant Infections in Low Income Countries
An observational study of Bacterial Infections, run by Institut Pasteur at 1 site in Madagascar.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- biological samples
- How many people
- 1,000 participants
- Where
- 1 siteMadagascar
- Study dates
- Sep 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: newborns
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Madagascar1 site, 1 recruiting
- Recruiting
institut pasteur in Madagascar
Antananarivo
Benoit Garin, MD, (261) 20 22 590 19, bgarin@pasteur.mg
About this study
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
- Conditions
- Bacterial Infections
- Being tested
- biological samples
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| newborns | Not described Receives: Biological: biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).
Measured: 27 months
Secondary outcomes (2)
Bacterial aetiology of neonatal infection in low income countries and its resistance
Measured: 27 months
Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur in Madagascar (subject recruitment), department of International cooperation of Monaco (funding)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074865
- Sponsor's protocol ID
- 2012-11 ChARLI
- Acronym
- ChARLI
- Status last verified
- Feb 2014
- First submitted
- 10 Jul 2013
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Antibiotic Resistant Infections in Low Income Countries
- ClinicalTrials.gov ID
- NCT02074865
- Acronym / sponsor ID
- ChARLI / 2012-11 ChARLI
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur in Madagascar (subject recruitment), department of International cooperation of Monaco (funding)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newborns | – | Biological: biological samples |
Who may qualify
- Ages
- 1 minute to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- newborns
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samples | Biological | newborns |
Primary outcome
Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).
Time frame: 27 months
2 secondary outcomes
Bacterial aetiology of neonatal infection in low income countries and its resistance
Time frame: 27 months
Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries
Time frame: 27 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Institut Pasteur at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Guillemot, MD, PhD (0145688301, didier.guillemot@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age). (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014; AzTrials last refreshed its copy on 26 Oct 2026.