Clinical trial NCT02434679: Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns
Official title: Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteriology
Keywords: antibiotics resistance integrons
neonatology newborns
digestive acquisition
dynamic of the acquisition of integrons
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 278
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


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

Primary outcomes:
measure: The occurrence over time of digestive acquisition of any type of RI
timeFrame: 3 weeks
Secondary outcomes:
measure: The occurrence over time of digestive acquisition of severals type of RI
timeFrame: 3 weeks
measure: Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Hospital center
city: Bordeaux
country: France
facility: University Hospital
city: Limoges
country: France
facility: University hospital
city: Pau
country: France
facility: Hospital center
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Antoine BEDU, MD
role: PRINCIPAL_INVESTIGATOR
References: