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

NCT04279873 — Completed, 22 participants, Zealand University Hospital

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

Registry	NCT04279873
Status	Completed
Study type	Observational
Enrollment	22 (Actual)
Sponsor	Zealand University Hospital (Other); collaborators: Slagelse Hospital
Conditions	Nosocomial Pneumonia
Interventions	Microbiological diagnostics on pulmonary secretion (Diagnostic test)
Dates	start 2014-05-01, primary completion 2020-12-31, completion 2020-12-31, first posted 2020-02-21, last updated 2021-04-22
Locations	1 site in Denmark

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Adults with nosocomial pneumonia		Diagnostic Test: Microbiological diagnostics on pulmonary secretion	Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.

Microbiological diagnostics on pulmonary secretion (Diagnostic test): Culture, 16s, 18s, next generation sequencing

+Outcome measures

Primary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Zealand University Hospital	Køge, Region Sjælland	Denmark

+Investigators

Lone Musaeus Poulsen, MD, Principal investigator, Zealand University Hospital

My Notes

Public

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