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

Completed

• Conditions: Bacteriology

• Registration Number: NCT02434679
• Lead Sponsor: University Hospital, Limoges

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 available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-05
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence over time of digestive acquisition of any type of RI	3 weeks

Secondary Outcome Measures

Name	Time	Method
The occurrence over time of digestive acquisition of severals type of RI	3 weeks	"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.
Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units	3 weeks	Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units

Trial Locations

Locations (3)

Hospital center; 🇫🇷 Pau, France

University hospital; 🇫🇷 Limoges, France

University Hospital; 🇫🇷 Toulouse, France