NCT02751658

Brief Summary

The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

November 8, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

March 4, 2016

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of Pseudomonas aeruginosa

    The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients admitted to the hospital entrance. Mark of Pseudomonas aeruginosa will be done with and without trypticase soy broth enrichment and isolation on selective agar cetrimide Pseudomonas aeruginosa . The enrichment will detect a port at very low inoculum knowing that the purpose of the analysis is to detect passing of Pseudomonas aeruginosa from the environment to the patient regardless of the associated infectivity. The identification of certainty will be carried out by MALDI-TOF. If several morphotypes are visualized on agar Cetrimide they will all be identified and kept under custody broth at -20 ° C.

    Entrance hospitalization (Day 1)

Secondary Outcomes (1)

  • Presence of infection with Pseudomonas aeruginosa

    Exit hospitalization (Day 10)

Study Arms (1)

patients in the Otorhinolaryngology

OTHER

patients in the Otorhinolaryngology department realization of a levy into the mouth swab on the day of admission to hospital and the day of release

Other: mouth swab

Interventions

Levy to make inside of the mouth with a swab on the day of admission to hospital and the day of release at the patients in the Otorhinolaryngology

patients in the Otorhinolaryngology

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in the Otorhinolaryngology department

You may not qualify if:

  • Immunocompromised patients
  • Patient Opposition to enter the research protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Benigno V, Carraro N, Sarton-Loheac G, Romano-Bertrand S, Blanc DS, van der Meer JR. Diversity and evolution of an abundant ICEclc family of integrative and conjugative elements in Pseudomonas aeruginosa. mSphere. 2023 Dec 20;8(6):e0051723. doi: 10.1128/msphere.00517-23. Epub 2023 Oct 30.

  • Virieux-Petit M, Hammer-Dedet F, Aujoulat F, Jumas-Bilak E, Romano-Bertrand S. From Copper Tolerance to Resistance in Pseudomonas aeruginosa towards Patho-Adaptation and Hospital Success. Genes (Basel). 2022 Feb 4;13(2):301. doi: 10.3390/genes13020301.

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Study Officials

  • Sara ROMANO-BERTRAND, MCU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

April 26, 2016

Study Start

November 8, 2016

Primary Completion

December 18, 2017

Study Completion

July 29, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07