The Role of Point-of-care Polymerase Chain Reaction in Ma... | NCT05928208

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

NCT05928208

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Status

Completed

Last Update Posted

Jul 3, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Nosocomial Pneumonia

Interventions

no intervention

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

May 30, 2023Actual

Completion Date

May 30, 2023Actual

First Submitted Date

Jun 18, 2017

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2023

Last Update Posted Date

Jul 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Balan Andrei Mihai, MD, Phd student, Iuliu Hatieganu University of Medicine and PharmacyPrincipal Investigator

Lead Sponsor

Iuliu Hatieganu University of Medicine and PharmacyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Diagnostic Test	no intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with symptoms of nosocomial pneumonia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrei Balan, MD	Universitatea de Medicina si Farmacie "Iuliu Hatieganu" Cluj-Napoca	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spitalul Clinic Judetean de Urgenta Cluj		Cluj-Napoca	Cluj		Romania

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia

Ancestor Terms

ID	Term
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided