Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia

NCT ID: NCT04279873

Last Updated: 2021-04-22

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-01

Study Completion Date

2020-12-31

Brief Summary

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Nosocomial pneumonia in the Intensive Care Unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. The study investigates the feasibility of more advanced diagnostic technics.

Detailed Description

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ICU patients fulfilling the CDC criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study. The material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage. The diagnostic procedures are culturing, 16S and18S gene PCR and subsequent sequencing. The 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.

Conditions

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Nosocomial Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults with nosocomial pneumonia

Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.

Microbiological diagnostics on pulmonary secretion

Intervention Type DIAGNOSTIC_TEST

Culture, 16s, 18s, next generation sequencing

Interventions

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Microbiological diagnostics on pulmonary secretion

Culture, 16s, 18s, next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients intubated because of respiratory failure following nosocomial pneumonia

Exclusion Criteria

* Terminal patients
* Patients with lung cancer
* Intubated for more than 24 hours at the sampling time
* Not fulfilling the CDC criteria for nosocomial pneumonia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Slagelse Hospital

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lone Musaeus Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

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Zealand University Hospital

Køge, Region Sjælland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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REG-48-2017

Identifier Type: OTHER

Identifier Source: secondary_id

REG-048-2014

Identifier Type: -

Identifier Source: org_study_id

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