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

Completed

• Conditions: Nosocomial Pneumonia
• Interventions: Diagnostic Test: Microbiological diagnostics on pulmonary secretion

• Registration Number: NCT04279873
• Lead Sponsor: Zealand University Hospital

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.

Study Timeline

• Study Start: 2014-05-01
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with nosocomial pneumonia	Microbiological diagnostics on pulmonary secretion	Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Region Sjælland, Denmark