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NCT05928208 Clinical Trial

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

Nosocomial Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05928208
Other study ID # 82/03.03.2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date May 30, 2023

Study information
Verified date June 2023
Source Universitatea de Medicina si Farmacie Iuliu Hatieganu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• no intervention
no intervention

Locations
Country Name City State
Romania Spitalul Clinic Judetean de Urgenta Cluj Cluj-Napoca Cluj

Sponsors (1)
Lead Sponsor Collaborator
Universitatea de Medicina si Farmacie Iuliu Hatieganu

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia Comparison between device and gold standard 4 years
Primary Utility of POC-PCR in managing pneumonia Decision making in pneumonia management 4 years
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