CClinicalTrials.gg
CompletedNCT04279873Updated Apr 22, 2021

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

An observational study in Nosocomial Pneumonia, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-22.

Sponsored by Zealand University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nosocomial Pneumonia

Keywords

  • Nosocomial, Pneumonia
  • Diagnostics
  • 16s
  • 18s
  • PCR
  • Next Generation Sequencing
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 22 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with nosocomial pneumonia and the need of mechanical ventilation not intubated for more than 24 hours.

Inclusion criteria

  • Patients intubated because of respiratory failure following nosocomial pneumonia

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adults with nosocomial pneumonia

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

    Diagnostic Test: Microbiological diagnostics on pulmonary secretion

Interventions

  • Diagnostic testMicrobiological diagnostics on pulmonary secretion

    Culture, 16s, 18s, next generation sequencing

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 day

07

Study locations

1 site
  • Zealand University Hospital
    Køge, Region Sjælland 4600, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04279873
Lead sponsor
Zealand University Hospital
Collaborators
Slagelse Hospital
Responsible party
Sponsor
First posted
Feb 21, 2020
Start date
May 1, 2014
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Apr 22, 2021

Study contacts

Lone Musaeus Poulsen, MD
principal investigator · Zealand University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion