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OpenTrials
Completed

NCT Number: NCT02434679

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

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

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Key information

Conditions

Bacteriology

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital center, Bayonne, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The occurrence over time of digestive acquisition of any type of RI

    Time frame: 3 weeks

Secondary outcomes

  1. The occurrence over time of digestive acquisition of severals type of RI

    Time frame: 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.

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

    Time frame: 3 weeks

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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: DAIR3N

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.