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

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.

Study Overview

• Status: Completed
• Conditions: Nosocomial Pneumonia
• Intervention / Treatment: Diagnostic test: Microbiological diagnostics on pulmonary secretion

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Denmark
  • Region Sjælland
    • Køge, Region Sjælland, Denmark, 4600
      • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with nosocomial pneumonia; Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.	Diagnostic test: Microbiological diagnostics on pulmonary secretion; Culture, 16s, 18s, next generation sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Slagelse Hospital
• Investigators: Principal Investigator: Lone Musaeus Poulsen, MD, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PCR; Diagnostics; Next Generation Sequencing; Nosocomial, Pneumonia; 16s; 18s
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia
• Other Study ID Numbers: REG-048-2014; REG-48-2017 (Other Identifier: The Danish Data Protection Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No