Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey

NCT04304456 | Unknown

• 1 other identifier: KA-19126
• Study Type: observational
• Target: 810
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this observational study, it is aimed to investigate the mortality and morbidity rates of hospital-acquired blood stream infections that are treated in intensive care units (ICU). The effects of properties of the micro-organism such as type and antimicrobial resistance on the infection and its outcomes will be mainly explored. In addition, the impact of antibiotic options and other treatment modalities on survival of patients will be investigated. Twenty-seven different ICUs from Turkey will be included in this study.

Conditions

Bacteremia; Sepsis; Hospital Acquired Condition

Keywords

Bacteremia; Antimicrobial resistance; Mortality; Hospital acquired infections

Outcome Measures

Primary Outcomes (1)

• Mortality Rate

  Rate of all cause mortality

  28-day mortality

Secondary Outcomes (4)

• Progress of organ failures

  7-day

• Days free or organ supportive therapy

  28-day

• Rate of Clinical cure

  7-day and 28-day

• Rate of Microbiological cure

  7-day and 28-day

Study Arms (1)

HA-BSI

Patients with HA-BSI treated in an ICU

Other: Treatment

Interventions

Treatment OTHER

Antimicrobial and other treatment modalities such as source control, vasoactive medications, dialysis

HA-BSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a HA-BSI treated in an ICU

You may qualify if:

• Age \> 18 Years.
• Hospital Acquired Bloodstream Infection (HA-BSI).
• Treated in the ICU.
• ICU acquired OR Hospital acquired prior to ICU admission

You may not qualify if:

• Patients that had a positive blood culture in the hospital and transferred to ICU for a different reason than specific treatment of the causes or consequences of HA-BSI.
• HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission.

Sponsors & Collaborators

• SCARE (Study group for carbapenem resistance): lead
• European Society of Intensive Care Medicine: collaborator

Related Publications (5)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.

  PMID: 19952319 BACKGROUND

• Tabah A, Koulenti D, Laupland K, Misset B, Valles J, Bruzzi de Carvalho F, Paiva JA, Cakar N, Ma X, Eggimann P, Antonelli M, Bonten MJ, Csomos A, Krueger WA, Mikstacki A, Lipman J, Depuydt P, Vesin A, Garrouste-Orgeas M, Zahar JR, Blot S, Carlet J, Brun-Buisson C, Martin C, Rello J, Dimopoulos G, Timsit JF. Characteristics and determinants of outcome of hospital-acquired bloodstream infections in intensive care units: the EUROBACT International Cohort Study. Intensive Care Med. 2012 Dec;38(12):1930-45. doi: 10.1007/s00134-012-2695-9. Epub 2012 Sep 26.

  PMID: 23011531 BACKGROUND

• De Waele JJ, Akova M, Antonelli M, Canton R, Carlet J, De Backer D, Dimopoulos G, Garnacho-Montero J, Kesecioglu J, Lipman J, Mer M, Paiva JA, Poljak M, Roberts JA, Rodriguez Bano J, Timsit JF, Zahar JR, Bassetti M. Antimicrobial resistance and antibiotic stewardship programs in the ICU: insistence and persistence in the fight against resistance. A position statement from ESICM/ESCMID/WAAAR round table on multi-drug resistance. Intensive Care Med. 2018 Feb;44(2):189-196. doi: 10.1007/s00134-017-5036-1. Epub 2017 Dec 29.

  PMID: 29288367 BACKGROUND

• PRISM Investigators; Rowan KM, Angus DC, Bailey M, Barnato AE, Bellomo R, Canter RR, Coats TJ, Delaney A, Gimbel E, Grieve RD, Harrison DA, Higgins AM, Howe B, Huang DT, Kellum JA, Mouncey PR, Music E, Peake SL, Pike F, Reade MC, Sadique MZ, Singer M, Yealy DM. Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis. N Engl J Med. 2017 Jun 8;376(23):2223-2234. doi: 10.1056/NEJMoa1701380. Epub 2017 Mar 21.

  PMID: 28320242 BACKGROUND

MeSH Terms

Conditions

Bacteremia; Sepsis; Iatrogenic Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Abdullah Tarık Aslan

CONTACT

+905346754889; aslanabdullahtarik@gmail.com

Murat Akova

CONTACT

akova.murat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 11, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: April 1, 2022
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share