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OpenTrials
Completed

NCT Number: NCT04279873

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

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.

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Key information

Conditions

Nosocomial Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Microbiological diagnostics on pulmonary secretion

Diagnostic Test

Culture, 16s, 18s, next generation sequencing

Primary outcomes

  1. Ratio of patients where the advanced methods are superior to routine

    Time frame: 1 day

    Ratio of patients diagnosed by 16s, 18s or NGS to total number of patients compared to ratio of patients diagnosed by routine method (culture)

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Slagelse Hospital

Registry information

Official study title

Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia in Patients Admitted to the Intensive Care Unit - an Exploratory Study

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2020
Registry last updated
Apr 22, 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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