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

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ClinicalTrials.gov Identifier: NCT02751658
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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

Condition or disease Intervention/treatment Phase
Otorhinolaryngologic Diseases Other: mouth swab Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections
Actual Study Start Date : November 8, 2016
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : July 29, 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Presence of Pseudomonas aeruginosa [ Time Frame: Entrance hospitalization (Day 1) ]

    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 :
  1. Presence of infection with Pseudomonas aeruginosa [ Time Frame: Exit hospitalization (Day 10) ]

    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.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in the Otorhinolaryngology department

Exclusion Criteria:

  • Immunocompromised patients
  • Patient Opposition to enter the research protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751658


Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Sara ROMANO-BERTRAND, MCU-PH University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02751658     History of Changes
Other Study ID Numbers: 9648
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Otorhinolaryngologic Diseases