Children's Antibiotic Resistant Infections in Low Income... | NCT02074865

Studies
Children's Antibiotic Resistant Infections in Low Income Countries

NCT02074865

Sponsor

Institut Pasteur

Status

Unknown status

Last Update Posted

Feb 28, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Bacterial Infections

Interventions

biological samples

Countries

Madagascar

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Mar 2014Estimated

Completion Date

Not provided

First Submitted Date

Jul 10, 2013

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Name	Class
Institut Pasteur in Madagascar (subject recruitment)	UNKNOWN
department of International cooperation of Monaco (funding)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
newborns			Biological: biological samples

Name	Type	Description	Arm Group Labels	Other Names
biological samples	Biological		newborns

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

3 Days

Standard Ages

Child

Study Population

newborns

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Didier Guillemot, MD, PhD	Contact	0145688301		didier.guillemot@pasteur.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
institut pasteur in Madagascar	Recruiting	Antananarivo			Madagascar

Label	URL
Related Info	View source

ID	Term
D001424	Bacterial Infections

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

Description

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