The Extended Study of Prevalence of Infection in Intensive Care IV
NCT ID: NCT07309549
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
10000 participants
OBSERVATIONAL
2026-03-31
2026-05-31
Brief Summary
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* What types of infections and antibiotic-resistant bacteria are most common in ICUs worldwide?
* How do resistance patterns affect how participants are treated and how they recover?
How are antibiotics used in ICUs, and how do hospitals practice antibiotic stewardship?
* What organ support treatments do participants with infections receive?
* What are the outcomes of participants with severe infections, including survival at hospital discharge (up to 60 days)?
Researchers will compare ICUs across regions and income levels to see how infection patterns, treatments, and outcomes differ around the world.
Participants will:
* Be counted if they are present in the ICU at any time during the study day.
* Have information collected from their medical record about their health, the infection they may have, treatments they receive, and their outcome at ICU and hospital discharge (up to 60 days).
Because this is an observational study, participants will not receive any new treatments as part of the study.
Detailed Description
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This study follows the methodology of previous EPIC initiatives (1998, 2007, 2017), while addressing the substantial changes in infection epidemiology observed in the post-COVID-19 era, including shifts in microbial resistance profiles and ICU practice patterns. Each participating ICU will select a single study day within the predefined window, during which all patients aged ≥18 years who are present in the unit at any time during the 24-hour period will be included.
Data collection will be standardized across sites and will include:
* Patient-level information on demographics, comorbidities, admission characteristics, severity-of-illness scores (APACHE II, SAPS II, SOFA), organ dysfunction, microbiology results, antimicrobial therapies, and supportive treatments.
* Unit-level characteristics related to ICU organization, staffing, resource availability, and antimicrobial stewardship practices.
* Follow-up data on ICU and hospital outcomes, censored at 60 days after the study day.
No study-specific treatments or interventions will be administered. All clinical care will follow local practice. Microbiological testing and therapeutic decisions will not be influenced by the study protocol.
EPIC IV will enable detailed analyses of global and regional variability in infection epidemiology, antimicrobial resistance, antibiotic stewardship performance, and resource utilization. The large international sample size will support predefined sub-studies examining associations between infection type, resistance patterns, comorbidities, ICU structural characteristics, and patient outcomes. The dataset will also allow stratified analyses based on country income level and geographical region, generating evidence relevant to both high-income and low- and middle-income countries.
This coordinated effort aims to produce a comprehensive and contemporary description of infectious disease burden in ICUs worldwide and to inform future clinical guidelines, policy development, and resource allocation.
Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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All patients present on or admitted to a contributing ICU on the study day
None interventions
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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St. James's Hospital, Ireland
OTHER
Universidad de la Sabana
OTHER
Responsible Party
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Principal Investigators
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Ignacio-Martin Loeches, MD, PhD, FJFICMI
Role: PRINCIPAL_INVESTIGATOR
St James' Hospital. Dublin, Ireland
Luis Felipe Reyes, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de La Sabana. Chia, Colombia
Jean-Louis Vincent, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital. Brussels, Belgium
Central Contacts
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References
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Wynne C. Improve your children .... change yourself! Caritas. 1990 Autumn;56(75):11. No abstract available.
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.
Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.
Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. 2004 Apr;30(4):589-96. doi: 10.1007/s00134-004-2157-0. Epub 2004 Feb 12.
Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. doi: 10.1007/s00134-003-2121-4. Epub 2004 Mar 2.
Weycker D, Akhras KS, Edelsberg J, Angus DC, Oster G. Long-term mortality and medical care charges in patients with severe sepsis. Crit Care Med. 2003 Sep;31(9):2316-23. doi: 10.1097/01.CCM.0000085178.80226.0B.
Padkin A, Goldfrad C, Brady AR, Young D, Black N, Rowan K. Epidemiology of severe sepsis occurring in the first 24 hrs in intensive care units in England, Wales, and Northern Ireland. Crit Care Med. 2003 Sep;31(9):2332-8. doi: 10.1097/01.CCM.0000085141.75513.2B.
Alberti C, Brun-Buisson C, Burchardi H, Martin C, Goodman S, Artigas A, Sicignano A, Palazzo M, Moreno R, Boulme R, Lepage E, Le Gall R. Epidemiology of sepsis and infection in ICU patients from an international multicentre cohort study. Intensive Care Med. 2002 Feb;28(2):108-21. doi: 10.1007/s00134-001-1143-z. Epub 2001 Dec 4.
Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
Other Identifiers
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Pending
Identifier Type: -
Identifier Source: org_study_id