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

Bacteriology Clinical Trial

— DAIR3N  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434679
• Other study ID #: I13024 DAIR3N
• Status: Completed
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Bacteriology

Locations

Country	Name	City	State
France	Hospital center	Bayonne
France	University Hospital	Bordeaux
France	University hospital	Limoges
France	Hospital center	Pau
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence over time of digestive acquisition of any type of RI		3 weeks
Secondary	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
Secondary	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