NCT03182387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2020

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

3.2 years

First QC Date

June 7, 2017

Last Update Submit

June 4, 2021

Conditions

Infectious PneumoniaComa

Keywords

Bronchoalveolar lavageamylase assayaspiration pneumonia

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificityof amylase test.

    Amylase culture in bronchoalveolar fluid is compared to gold standard culture

    5 days after inclusion day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted to ICU with mechanical ventilation need.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pellegrin

Bordeaux, 33000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchoalveolar fluid.

MeSH Terms

Conditions

ComaPneumonia, Aspiration

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Linda Wittkop, PhD

    USMR

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 9, 2017

Study Start

August 21, 2017

Primary Completion

November 19, 2020

Study Completion

November 19, 2020

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)