NCT04926935

Brief Summary

Hospital-acquired bloodstream infection (BSI) is serious care problem worldwide associated with significant morbidity and mortality. However, only few nationwide studies have focused on the incidence of BSI, and its results were often inconsistent. The objective of this study was to analyze bloodstream infections in patients hospitalized in the intensive care unit of the tertiary, university hospital. Special attention was put on the etiology of the infections, the antimicrobial susceptibility/resistance of the isolated pathogens, as well as the incidence of central vein catheters infections in the analyzed population. Data were collected in the intensive care unit of the Military Institute of Medicine, Warsaw, Poland, between January, 1, 2007 and December, 31, 2019.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

13 years

First QC Date

June 4, 2021

Last Update Submit

June 8, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Results of microbiological analysis.

    Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.

    After completion of the microbiological analysis, up to 72 hours.

  • Isolated pathogens' susceptibility for antimicrobial agents. .

    Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.

    After completion of the microbiological analysis, up to 72 hours.

  • Isolated pathogens' resistance for antimicrobial agents. .

    Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.

    After completion of the microbiological analysis, up to 72 hours.

Study Arms (1)

Patients hospitalized in the ICU during the study period.

Patients hospitalized in the ICU during the study period with clinically suspected infection.

Diagnostic Test: Microbiological analysis of blood samples.

Interventions

Microbiological analysis of blood samples collected from the patients with clinically suspected infection.

Patients hospitalized in the ICU during the study period.

Eligibility Criteria

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

All patients hospitalized in the ICU with clinically suspected infection between 2007-2019.

You may qualify if:

  • all patients hospitalized in the ICU with clinically suspected infection.

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Location

Related Publications (6)

  • Garrouste-Orgeas M, Timsit JF, Tafflet M, Misset B, Zahar JR, Soufir L, Lazard T, Jamali S, Mourvillier B, Cohen Y, De Lassence A, Azoulay E, Cheval C, Descorps-Declere A, Adrie C, Costa de Beauregard MA, Carlet J; OUTCOMEREA Study Group. Excess risk of death from intensive care unit-acquired nosocomial bloodstream infections: a reappraisal. Clin Infect Dis. 2006 Apr 15;42(8):1118-26. doi: 10.1086/500318. Epub 2006 Mar 14.

  • Laupland KB, Lee H, Gregson DB, Manns BJ. Cost of intensive care unit-acquired bloodstream infections. J Hosp Infect. 2006 Jun;63(2):124-32. doi: 10.1016/j.jhin.2005.12.016. Epub 2006 Apr 18.

  • Wilson J, Elgohari S, Livermore DM, Cookson B, Johnson A, Lamagni T, Chronias A, Sheridan E. Trends among pathogens reported as causing bacteraemia in England, 2004-2008. Clin Microbiol Infect. 2011 Mar;17(3):451-8. doi: 10.1111/j.1469-0691.2010.03262.x.

  • Nielsen SL, Pedersen C, Jensen TG, Gradel KO, Kolmos HJ, Lassen AT. Decreasing incidence rates of bacteremia: a 9-year population-based study. J Infect. 2014 Jul;69(1):51-9. doi: 10.1016/j.jinf.2014.01.014. Epub 2014 Feb 25.

  • de Kraker ME, Jarlier V, Monen JC, Heuer OE, van de Sande N, Grundmann H. The changing epidemiology of bacteraemias in Europe: trends from the European Antimicrobial Resistance Surveillance System. Clin Microbiol Infect. 2013 Sep;19(9):860-8. doi: 10.1111/1469-0691.12028. Epub 2012 Oct 8.

  • Goto M, Al-Hasan MN. Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe. Clin Microbiol Infect. 2013 Jun;19(6):501-9. doi: 10.1111/1469-0691.12195. Epub 2013 Mar 8.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dariusz Tomaszewski, MD, PhD

    Military Institute od Medicine National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 15, 2021

Study Start

January 1, 2007

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations