Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns (DAIR3N)

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

Study Overview

• Status: Completed
• Conditions: Bacteriology

• Study Type: Observational
• Enrollment (Actual): 278

Contacts and Locations

Study Locations

• France
  • Bayonne, France, 64109
    • Hospital center
  • Bordeaux, France, 33076
    • University Hospital
  • Limoges, France, 87042
    • University Hospital
  • Pau, France, 64000
    • Hospital center
  • Toulouse, France, 31059
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units	Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units	3 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Antoine BEDU, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: antibiotics resistance integrons; neonatology newborns; digestive acquisition; dynamic of the acquisition of integrons
• Other Study ID Numbers: I13024 DAIR3N

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No