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Key to Improve DiagNosis in Aspiration Pneumonia (KIDNAP)

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ClinicalTrials.gov Identifier: NCT03182387
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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
Infectious Pneumonia Coma

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
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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 : August 21, 2017
Actual Primary Completion Date : November 19, 2020
Actual Study Completion Date : November 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and specificityof amylase test. [ Time Frame: 5 days after inclusion day ]
    Amylase culture in bronchoalveolar fluid is compared to gold standard culture


Biospecimen Retention:   Samples Without DNA
bronchoalveolar fluid.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient admitted to ICU with mechanical ventilation need.
Criteria

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
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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): NCT03182387


Locations
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France
Hôpital Pellegrin
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Linda Wittkop, PhD USMR
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03182387    
Other Study ID Numbers: CHUBX 2015/38
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Bronchoalveolar lavage
amylase assay
aspiration pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections