NCT05928208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

6.3 years

First QC Date

June 18, 2017

Last Update Submit

June 22, 2023

Conditions

Nosocomial Pneumonia

Keywords

polymerase chain reaction

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

no interventionDIAGNOSTIC_TEST

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with symptoms of nosocomial pneumonia

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spitalul Clinic Judetean de Urgenta Cluj

Cluj-Napoca, Cluj, Romania

Location

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrei Balan, MD

    Universitatea de Medicina si Farmacie "Iuliu Hatieganu" Cluj-Napoca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd student

Study Record Dates

First Submitted

June 18, 2017

First Posted

July 3, 2023

Study Start

February 1, 2017

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)