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Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns (DAIR3N)

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ClinicalTrials.gov Identifier: NCT02434679
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Bacteriology

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Study Type : Observational
Actual Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns
Study Start Date : October 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. The occurrence over time of digestive acquisition of any type of RI [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  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


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.



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434679


Locations
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France
Hospital center
Bayonne, France, 64109
University Hospital
Bordeaux, France, 33076
University hospital
Limoges, France, 87042
Hospital center
Pau, France, 64000
University Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Antoine BEDU, MD University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02434679    
Other Study ID Numbers: I13024 DAIR3N
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Keywords provided by University Hospital, Limoges:
antibiotics resistance integrons
neonatology newborns
digestive acquisition
dynamic of the acquisition of integrons