NCT02203110

Brief Summary

The purpose of the study is to determine if the clinical course of pneumonia is more severe when both, bacterial and viral pathogens are find as possible causative agent and how does it affect treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

July 25, 2014

Last Update Submit

July 25, 2014

Conditions

Community Acquired PneumoniaHospital Acquired PneumoniaVentilator Associated Pneumonia

Keywords

simultaneous bacterial and viral pneumonia

Outcome Measures

Primary Outcomes (1)

  • Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic

    each patient will be assessed at enrollment and follow-up for 2 months

Eligibility Criteria

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

Adult patients admited to Intensive Care Unit Department of Infectious Diseases University Medical Centre Ljubljana due to severe pneumonia or pneumonia will develop during their stay in ICU.

You may qualify if:

  • severe community acquired pneumonia or
  • severe hospital acquired pneumonia or
  • ventilator--associated pneumonia

You may not qualify if:

  • antibiotic treatment of actual episode of pneumonia for more than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2

Ljubljana, 1000, Slovenia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, two 7 ml samples

MeSH Terms

Conditions

Community-Acquired PneumoniaHealthcare-Associated PneumoniaPneumonia, Ventilator-AssociatedPneumonia, Viral

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesCross InfectionLung DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus Diseases

Study Officials

  • Primoz Karner

    Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Primoz Karner

CONTACT

+386 51 345616primoz.karner@guest.arnes.si

Matjaz Jereb

CONTACT

+386 1 522 8170matjaz.jereb@kclj.si

Study Design

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

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 29, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

SL(1)