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Completed

NCT Number: NCT03182387

Key to Improve DiagNosis in Aspiration Pneumonia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificityof amylase test.

    Time frame: 5 days after inclusion day

    Amylase culture in bronchoalveolar fluid is compared to gold standard culture

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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.

Acronym: KIDNAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2017
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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