Dynamic of the Acquisition of Antibiotic Resistance in In... | NCT02434679

Studies
Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns

NCT02434679

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Oct 24, 2019Actual

Enrollment

278Actual

Phase

Not provided

Conditions

Bacteriology

Interventions

Not provided

Countries

France

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 5, 2015Estimated

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

Oct 23, 2019

Last Update Posted Date

Oct 24, 2019Actual

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

Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are increasing. Among the actions to control resistance, one is an interesting lead: to prevent the emergence of resistant bacteria by limiting possibilities for bacteria to acquire resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few data on the dynamic of acquisition over time. Among the genetic components that disseminate resistance genes, resistance integrons (RI) play a major role in the acquisition and dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the first days of life. It thus appears to be an appropriate model to study the dynamic of resistance acquisition. This project intends to follow the NB of neonatology over time in order to study the dynamic of the digestive acquisition of RI and MRB

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

278Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The occurrence over time of digestive acquisition of any type of RI		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
The occurrence over time of digestive acquisition of severals type of RI	"intI1" whenever the gene encoding a class 1 integrase will be detected "intI2" whenever the gene encoding a class 2 integrase will be detected "intI3" whenever the gene encoding a class 3 integrase will be detected An association: "intI1+intI2", "intI1+intI3", "intI2+intI3", "intI1+intI2+intI3" will also be searched.	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mother-child pairs that will be included in the study will be the pairs of all the NB, born in the center (in born) and hospitalized in the neonatology units of each center:

with a predictable stay ≥ 3 weeks in the unit

Exclusion Criteria:

NB will not be included if:

They exhibit a birth defect, especially on the digestive tract
They are secondarily hospitalized after a postnatal transfer (out born).
The parents express their objection for the child to take part in the study
The stool sample of the mother has not been received

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Day

Standard Ages

Child

Study Population

Mother-child pairs of all the NB, born in the center and hospitalized in the neonatology units of each center with a predictable stay ≥ 3 weeks in the unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antoine BEDU, MD	University Hospital, Limoges	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital center		Bayonne		64109	France
University Hospital

Description

The meconium or the first stool will be sampled at D0. The stool will then be sampled: at D7, at D21 and every 15 days until the day of discharge.

If the NB has no stool on the given day, a period of 3 more days will be accepted from the day the sampling was planned. After this period, "no sample" will be stated.

Meconiums and stool must be sampled in sterile jars, labelled and sent with the designation "DAIR3N protocol" to the bacteriology laboratory of each center. If the local laboratory cannot seed the samples 7 days a week, stool samples can be kept maximum 48h at +4°C before management.

In the mother

Vaginal sample will be taken during the delivery according to care practices of each center if:

it is a preterm vaginal delivery, early membrane rupture happens, there is a threat of very preterm delivery. About 55% of inclusions should be subject to this type of sampling. Sampling of mother's stool will be asked at the inclusion.