BacteriologyDAIR3NNCT02434679
Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns
An observational study of Bacteriology, run by University Hospital, Limoges at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Bacteriology
- How many people
- 278 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hospital center
Bayonne, 64109
University Hospital
Bordeaux, 33076
University hospital
Limoges, 87042
Hospital center
Pau, 64000
University Hospital
Toulouse, 31059
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence over time of digestive acquisition of any type of RI
Measured: 3 weeks
Secondary outcomes (2)
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.
Measured: 3 weeks
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteriologyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BEDU, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434679
- Sponsor's protocol ID
- I13024 DAIR3N
- Acronym
- DAIR3N
- Status last verified
- Oct 2019
- First submitted
- 30 Apr 2015
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns
- ClinicalTrials.gov ID
- NCT02434679
- Acronym / sponsor ID
- DAIR3N / I13024 DAIR3N
- Conditions
- Bacteriology
- Keywords
- antibiotics resistance integrons, neonatology newborns, digestive acquisition, dynamic of the acquisition of integrons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurrence over time of digestive acquisition of any type of RI
Time frame: 3 weeks
2 secondary outcomes
The occurrence over time of digestive acquisition of severals type of RI
Time frame: 3 weeks
Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine BEDU, MD principal investigator
University Hospital, Limoges
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteriology, run by University Hospital, Limoges at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence over time of digestive acquisition of any type of RI (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.