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

Completed

• Conditions: Nosocomial Pneumonia

• Registration Number: NCT05928208
• Lead Sponsor: Universitatea de Medicina si Farmacie Iuliu Hatieganu

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-06-18
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia	4 years	Comparison between device and gold standard
Utility of POC-PCR in managing pneumonia	4 years	Decision making in pneumonia management

Trial Locations

Locations (1)

Spitalul Clinic Judetean de Urgenta Cluj; 🇷🇴 Cluj-Napoca, Cluj, Romania