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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04926935
Other study ID # 09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2007
Est. completion date December 31, 2019

Study information

Verified date June 2021
Source Military Institute of Medicine, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3502
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients hospitalized in the ICU with clinically suspected infection. Exclusion Criteria: - none.

Study Design


Intervention

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

Locations

Country Name City State
Poland Department of Anesthesiology and Intensive Therapy Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (6)

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 — View Citation

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 d — View Citation

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. Review. — View Citation

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. Epub 2006 Apr 18. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
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