Bloodstream InfectionNCT04926935
Bloodstram Infections in ICU. Single Centre Observational Study.
An observational study of Bloodstream Infection and Antibiotic Resistant Strain, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection, Antibiotic Resistant Strain, Intensive Care Unit
- What is being tested?
- Microbiological analysis of blood samples.
- How many people
- 3,502 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2007to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients hospitalized in the ICU with clinically suspected infection between 2007-2019.
Who may be able to join
- all patients hospitalized in the ICU with clinically suspected infection.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bloodstram Infections in Intensive Care Unit. A Single Centre Bacteriological Analysis Between 2007-2019.
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.
- Being tested
- Microbiological analysis of blood samples.
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological analysis of blood samples.Diagnostic test
Microbiological analysis of blood samples collected from the patients with clinically suspected infection.
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized in the ICU during the study period. | Patients hospitalized in the ICU during the study period with clinically suspected infection. Receives: Diagnostic Test: Microbiological analysis of blood samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: After completion of the microbiological analysis, up to 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jan 2007
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dariusz Tomaszewski, Military Institute od Medicine National Research Institute
- Investigators
- Dariusz Tomaszewski, MD, PhD, Principal investigator, Military Institute od Medicine National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926935
- Sponsor's protocol ID
- 09
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16575729Laupland 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.
PubMed 16621137Wilson 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.
PubMed 20491834Nielsen 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.
PubMed 24576825de 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.
PubMed 23039210Goto 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.
PubMed 23473333
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bloodstram Infections in Intensive Care Unit. A Single Centre Bacteriological Analysis Between 2007-2019.
- ClinicalTrials.gov ID
- NCT04926935
- Acronym / sponsor ID
- 09
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,502 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized in the ICU during the study period. | – | Diagnostic Test: Microbiological analysis of blood samples.Patients hospitalized in the ICU during the study period with clinically suspected infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized in the ICU with clinically suspected infection between 2007-2019.
Key inclusion criteria (1 listed)
- all patients hospitalized in the ICU with clinically suspected infection.
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological analysis of blood samples.Microbiological analysis of blood samples collected from the patients with clinically suspected infection. | Diagnostic test | Patients hospitalized in the ICU during the study period. |
Primary outcome
Results of microbiological analysis.
Time frame: After completion of the microbiological analysis, up to 72 hours.
Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.
Isolated pathogens' susceptibility for antimicrobial agents. .
Time frame: After completion of the microbiological analysis, up to 72 hours.
Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.
Isolated pathogens' resistance for antimicrobial agents. .
Time frame: After completion of the microbiological analysis, up to 72 hours.
Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Results publication: PubMed 16575729Garrouste-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.
- Results publication: PubMed 16621137Laupland 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.
- Results publication: PubMed 20491834Wilson 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.
- Results publication: PubMed 24576825Nielsen 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.
- Results publication: PubMed 23039210de 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.
- Results publication: PubMed 23473333Goto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariusz Tomaszewski, MD, PhD principal investigator
Military Institute od Medicine National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection and Antibiotic Resistant Strain, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of microbiological analysis. (time frame: After completion of the microbiological analysis, up to 72 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04926935, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.