Key to Improve DiagNosis in Aspiration Pneumonia (KIDNAP)

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.

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.

Study Overview

• Status: Completed
• Conditions: Coma; Infectious Pneumonia

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 Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hôpital Pellegrin

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patient admitted to ICU with mechanical ventilation need.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificityof amylase test.	Amylase culture in bronchoalveolar fluid is compared to gold standard culture	5 days after inclusion day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Linda Wittkop, PhD, USMR

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): November 19, 2020
• Study Completion (Actual): November 19, 2020

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Bronchoalveolar lavage; aspiration pneumonia; amylase assay
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: CHUBX 2015/38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No