KIDNAP: Key to Improve DiagNosis in Aspiration Pneumonia

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT03182387
Collaborator
(none)
69
1
39
1.8

Study Details

Study Description

Brief Summary

To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    69 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.
    Actual Study Start Date :
    Aug 21, 2017
    Actual Primary Completion Date :
    Nov 19, 2020
    Actual Study Completion Date :
    Nov 19, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificityof amylase test. [5 days after inclusion day]

      Amylase culture in bronchoalveolar fluid is compared to gold standard culture

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).

    • Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °> 38 ° C).

    • Age ≥18 years

    • Patient affiliated to the social security system.

    • No opposition obtained

    Exclusion Criteria:
    • Immunocompromised patient.

    • Cardiorespiratory arrest requiring therapeutic hypothermia.

    • Pneumopathy nosocomiale (pneumopathy beginning> 48h after hospital admission).

    • Infectious Pneumonia in the previous 30 days.

    • Previous hospitalization in the previous 30 days.

    • Patient under antibiotic at baseline.

    • Bacteremia.

    • Mechanical ventilation begun before unconsciousness.

    • Report Pa02 / FI02 <80.

    • Patient under curatorship and / or guardianship.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Pellegrin Bordeaux France 33000

    Sponsors and Collaborators

    • University Hospital, Bordeaux

    Investigators

    • Study Chair: Linda Wittkop, PhD, USMR

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Bordeaux
    ClinicalTrials.gov Identifier:
    NCT03182387
    Other Study ID Numbers:
    • CHUBX 2015/38
    First Posted:
    Jun 9, 2017
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Bordeaux
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2021