search
Back to results

Tap to "Tap", Pathobiome Associates Health Care (TapPAS)

Primary Purpose

Otorhinolaryngologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mouth swab
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Otorhinolaryngologic Diseases

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in the Otorhinolaryngology department

Exclusion Criteria:

  • Immunocompromised patients
  • Patient Opposition to enter the research protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    patients in the Otorhinolaryngology

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Presence of infection with Pseudomonas aeruginosa
    The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients exit hospitalization. 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.

    Full Information

    First Posted
    March 4, 2016
    Last Updated
    July 29, 2019
    Sponsor
    University Hospital, Montpellier
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02751658
    Brief Title
    Tap to "Tap", Pathobiome Associates Health Care
    Acronym
    TapPAS
    Official Title
    Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 8, 2016 (Actual)
    Primary Completion Date
    December 18, 2017 (Actual)
    Study Completion Date
    July 29, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    Goals : Key: To study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium. secondary: Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources. To evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with P. aeruginosa. Experimental Study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Otorhinolaryngologic Diseases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    410 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patients in the Otorhinolaryngology
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    mouth swab
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Presence of Pseudomonas aeruginosa
    Description
    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.
    Time Frame
    Entrance hospitalization (Day 1)
    Secondary Outcome Measure Information:
    Title
    Presence of infection with Pseudomonas aeruginosa
    Description
    The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients exit hospitalization. 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.
    Time Frame
    Exit hospitalization (Day 10)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients in the Otorhinolaryngology department Exclusion Criteria: Immunocompromised patients Patient Opposition to enter the research protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sara ROMANO-BERTRAND, MCU-PH
    Organizational Affiliation
    University Hospital, Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35205346
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Tap to "Tap", Pathobiome Associates Health Care

    We'll reach out to this number within 24 hrs