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Clinical Trials/NCT05928208
NCT05928208
Completed
Not Applicable

The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia

Universitatea de Medicina si Farmacie Iuliu Hatieganu1 site in 1 country60 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nosocomial Pneumonia
Sponsor
Universitatea de Medicina si Farmacie Iuliu Hatieganu
Enrollment
60
Locations
1
Primary Endpoint
To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study compares a device that is used for the detection of bacteria and MDR pathogens from skin, soft tissue and nose with the gold-standard (microbiological lab). It is a novel use for this device because it has been used in samples from the lower-respiratory tract.

Detailed Description

The purpose of this study is to find out if a POC-PCR device can be use in the diagnosis of hospital acquired pneumonia and ventilation-associated pneumonia.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
May 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Balan Andrei Mihai

MD, Phd student

Universitatea de Medicina si Farmacie Iuliu Hatieganu

Eligibility Criteria

Inclusion Criteria

  • patients that are admitted for at least 48 hours
  • radiological findings typical for pneumonia
  • signs of infection

Exclusion Criteria

  • patient or patient relatives doesn't accept to enter the study

Outcomes

Primary Outcomes

To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia

Time Frame: 4 years

Comparison between device and gold standard

Utility of POC-PCR in managing pneumonia

Time Frame: 4 years

Decision making in pneumonia management

Study Sites (1)

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