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

June 22, 2023 updated by: Balan Andrei Mihai, Universitatea de Medicina si Farmacie Iuliu Hatieganu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania
        • Spitalul Clinic Judetean De Urgenta Cluj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with symptoms of nosocomial pneumonia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitatea de Medicina si Farmacie Iuliu Hatieganu

Investigators

  • Principal Investigator: Andrei Balan, MD, Universitatea de Medicina si Farmacie "Iuliu Hatieganu" Cluj-Napoca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

June 18, 2017

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82/03.03.2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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