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

NCT02434679 | Completed

• 1 other identifier: I13024 DAIR3N
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 5

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

Conditions

Bacteriology

Keywords

antibiotics resistance integrons; neonatology newborns; digestive acquisition; dynamic of the acquisition of integrons

Outcome Measures

Primary Outcomes (1)

• The occurrence over time of digestive acquisition of any type of RI

  3 weeks

Secondary Outcomes (2)

• The occurrence over time of digestive acquisition of severals type of RI

  3 weeks

• Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units

  3 weeks

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (5)

Hospital center

Bayonne, 64109, France

Location

University Hospital

Bordeaux, 33076, France

Location

University hospital

Limoges, 87042, France

Location

Hospital center

Pau, 64000, France

Location

University Hospital

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• Antoine BEDU, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

FR (5)