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NCT04279873 Clinical Trial

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

Nosocomial Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04279873
Other study ID # REG-048-2014
Secondary ID REG-48-2017
Status Completed
Phase
First received
Last updated
Start date May 1, 2014
Est. completion date December 31, 2020

Study information
Verified date April 2021
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Microbiological diagnostics on pulmonary secretion
Culture, 16s, 18s, next generation sequencing

Locations
Country Name City State
Denmark Zealand University Hospital Køge Region Sjælland

Sponsors (2)
Lead Sponsor Collaborator
Zealand University Hospital Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ratio of patients where the advanced methods are superior to routine Ratio of patients diagnosed by 16s, 18s or NGS to total number of patients compared to ratio of patients diagnosed by routine method (culture) 1 day
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