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
About this trial
This is an interventional diagnostic trial for Otorhinolaryngologic Diseases
Eligibility Criteria
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
NCT ID
NCT02751658
First Posted
March 4, 2016
Last Updated
July 29, 2019
Sponsor
University Hospital, Montpellier
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
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Tap to "Tap", Pathobiome Associates Health Care
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