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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04279873

Enrollment

Registered

2020-02-21

Start date

2014-05-01

Completion date

2020-12-31

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nosocomial Pneumonia

Keywords

Nosocomial, Pneumonia, Diagnostics, 16s, 18s, PCR, Next Generation Sequencing

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTMicrobiological diagnostics on pulmonary secretion

Culture, 16s, 18s, next generation sequencing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ratio of patients where the advanced methods are superior to routine	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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026