Key to Improve DiagNosis in Aspiration Pneumonia

NCT ID: NCT03182387

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-21

Study Completion Date

2020-11-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infectious Pneumonia Coma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Wittkop, PhD

Role: STUDY_CHAIR

USMR

Locations

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Hôpital Pellegrin

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2015/38

Identifier Type: -

Identifier Source: org_study_id

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