The Extended Study of Prevalence of Infection in Intensive Care IV

NCT07309549 | Not Yet Recruiting

• 1 other identifier: Pending
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn how common infections are in intensive care units (ICUs) around the world and how they are treated. The study will look at all adults in the ICU during a single 24-hour period. The main questions it aims to answer are:

• 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.

Conditions

Sepsis; Infection

Keywords

Intensive Care Unit; Critical Illness; Severe Infection; Organ Dysfunction; ICU Outcomes; Global Prevalence

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at hospital discharge

  The primary outcome measure is all-cause mortality at hospital discharge, censored at 60 days from the study day. Mortality status will be assessed at ICU discharge and again at hospital discharge or Day 60, whichever occurs first.

  Up to 60 days after the study day

Secondary Outcomes (4)

• ICU mortality

  From ICU admission to ICU discharge (up to 60 days)

• ICU and hospital lengths of stay

  From ICU/hospital admission to discharge (up to 60 days)

• Organ Failure

  From ICU/hospital admission to discharge (up to 60 days)

• Antimicrobial Resistance

  From ICU/hospital admission to discharge (up to 60 days)

Study Arms (1)

All patients present on or admitted to a contributing ICU on the study day

None interventions

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

A worldwide sample of adult patients who are present in participating intensive care units during a single 24-hour study period, regardless of diagnosis, treatment, or reason for ICU admission.

You may qualify if:

• All adult patients (\>18 years) treated in the participating ICUs on the study day.

You may not qualify if:

• Patients under 18 years

Sponsors & Collaborators

• Universidad de la Sabana: lead
• St. James's Hospital, Ireland: collaborator

Related Publications (10)

• Wynne C. Improve your children .... change yourself! Caritas. 1990 Autumn;56(75):11. No abstract available.

  PMID: 2207816 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

• 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.

  PMID: 7637145 BACKGROUND

• 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.

  PMID: 14963646 BACKGROUND

• 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.

  PMID: 14997295 BACKGROUND

• 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.

  PMID: 14501962 BACKGROUND

• 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.

  PMID: 14501964 BACKGROUND

• 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.

  PMID: 11907653 BACKGROUND

• 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.

  PMID: 12700374 BACKGROUND

• 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.

  PMID: 11445675 BACKGROUND

MeSH Terms

Conditions

Sepsis; Infections; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Ignacio-Martin Loeches, MD, PhD, FJFICMI

  St James' Hospital. Dublin, Ireland

  PRINCIPAL INVESTIGATOR

• Luis Felipe Reyes, MD, MSc, PhD

  Universidad de La Sabana. Chia, Colombia

  PRINCIPAL INVESTIGATOR

• Jean-Louis Vincent, MD, PhD

  Erasme University Hospital. Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Felipe Reyes, MD, MSc, PhD

CONTACT

+57 317 5130128; luis.reyes5@unisabana.edu.co

Ignacio-Martin Loeches, MD, PhD, FJFICMI

CONTACT

drmartinloeches@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12