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Otorhinolaryngologic Diseases Clinical Trial

— TapPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751658
• Other study ID #: 9648
• Status: Completed
• Phase: N/A
• Start date: November 8, 2016
• Est. completion date: July 29, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: July 29, 2019
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients in the Otorhinolaryngology department

Exclusion Criteria:

• Immunocompromised patients

• Patient Opposition to enter the research protocol

Related Conditions & MeSH terms

• Otorhinolaryngologic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)