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

Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections

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

Study Overview

• Status: Completed
• Conditions: Otorhinolaryngologic Diseases
• Intervention / Treatment: Other: mouth swab

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:

1. Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources.
2. 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

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients in the Otorhinolaryngology department

Exclusion Criteria:

• Immunocompromised patients
• Patient Opposition to enter the research protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients in the Otorhinolaryngology; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Exit hospitalization (Day 10)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sara ROMANO-BERTRAND, MCU-PH, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2016
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): July 29, 2019

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases
• Other Study ID Numbers: 9648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED