SepsisEPIC IVNCT07309549
The Extended Study of Prevalence of Infection in Intensive Care IV
An observational study of Sepsis and Infection, run by Universidad de la Sabana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- All adult patients (>18 years) treated in the participating ICUs on the study day.
Who cannot join
- Patients under 18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ignacio-Martin Loeches, MD, PhD, FJFICMI contact
About this study
Official title: The Extended Study of Prevalence of Infection in Intensive Care IV (EPIC IV)
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?
Read more
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.
Read the detailed description
The Extended Prevalence of Infection in Intensive Care IV (EPIC IV) study is an international, multicenter, prospective 24-hour point-prevalence study designed to provide an updated global assessment of infection patterns, antimicrobial use, organ support strategies, and related outcomes among adult patients treated in intensive care units (ICUs).
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.
- Keywords
- Intensive Care Unit, Critical Illness, Severe Infection, Organ Dysfunction, ICU Outcomes, Global Prevalence
- Medical subject headings
- Sepsis, Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients present on or admitted to a contributing ICU on the study day | None interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 days after the study day
Secondary outcomes (4)
ICU mortality
Proportion of enrolled patients who die during their stay in the Intensive Care Unit (ICU). Mortality will be assessed based on ICU discharge status and used to evaluate short-term outcomes among critically ill patients included in the study.
Measured: From ICU admission to ICU discharge (up to 60 days)
ICU and hospital lengths of stay
Duration of stay measured as the total number of days each patient spends in the ICU and the hospital, from admission until ICU and hospital discharge. These measures will be used to evaluate disease severity, resource utilization, and patient recovery patterns.
Measured: From ICU/hospital admission to discharge (up to 60 days)
Organ Failure
Occurrence of new or worsening organ failure during ICU or hospital stay, assessed using validated clinical criteria (e.g., components of the SOFA score). Organ dysfunction will be evaluated to characterize severity of illness and its association with outcomes.
Measured: From ICU/hospital admission to discharge (up to 60 days)
Antimicrobial Resistance
Presence and characterization of antimicrobial-resistant pathogens isolated from clinical specimens during ICU or hospital stay. Resistance will be defined according to standard microbiological and susceptibility testing methods and used to assess the burden and patterns of antimicrobial resistance across participating centers.
Measured: From ICU/hospital admission to discharge (up to 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio-Martin Loeches, MD, PhD, FJFICMI, Principal investigator, St James' Hospital. Dublin, IrelandJean-Louis Vincent, MD, PhD, Principal investigator, Erasme University Hospital. Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309549
- Sponsor's protocol ID
- Acta No. 700 23-Jan-2026
- Acronym
- EPIC IV
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the sharing of individual participant data has not yet been finalized. IPD availability will depend on ethical approvals, institutional policies, and data-governance requirements across participating sites.
Publications
Wynne C. Improve your children .... change yourself! Caritas. 1990 Autumn;56(75):11. No abstract available.
PubMed 2207816Vincent 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.
PubMed 19952319Vincent 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.
PubMed 7637145Finfer 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.
PubMed 14963646Brun-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.
PubMed 14997295Weycker 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.
PubMed 14501962Padkin 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.
PubMed 14501964Alberti 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.
PubMed 11907653Martin 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.
PubMed 12700374Angus 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.
PubMed 11445675
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extended Study of Prevalence of Infection in Intensive Care IV (EPIC IV)
- ClinicalTrials.gov ID
- NCT07309549
- Acronym / sponsor ID
- EPIC IV / Acta No. 700 23-Jan-2026
- Keywords
- Intensive Care Unit, Critical Illness, Severe Infection, Organ Dysfunction, ICU Outcomes, Global Prevalence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Dec 2025 (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.
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.
Detailed description
The Extended Prevalence of Infection in Intensive Care IV (EPIC IV) study is an international, multicenter, prospective 24-hour point-prevalence study designed to provide an updated global assessment of infection patterns, antimicrobial use, organ support strategies, and related outcomes among adult patients treated in intensive care units (ICUs).
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients present on or admitted to a contributing ICU on the study day | – | –None interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients (>18 years) treated in the participating ICUs on the study day.
Key exclusion criteria (1 listed)
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality at hospital discharge
Time frame: Up to 60 days after the study day
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.
4 secondary outcomes
ICU mortality
Time frame: From ICU admission to ICU discharge (up to 60 days)
ICU and hospital lengths of stay
Time frame: From ICU/hospital admission to discharge (up to 60 days)
Organ Failure
Time frame: From ICU/hospital admission to discharge (up to 60 days)
Antimicrobial Resistance
Time frame: From ICU/hospital admission to discharge (up to 60 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 2207816Wynne C. Improve your children .... change yourself! Caritas. 1990 Autumn;56(75):11. No abstract available.
- Background: PubMed 19952319Vincent 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.
- Background: PubMed 7637145Vincent 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.
- Background: PubMed 14963646Finfer 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.
- Background: PubMed 14997295Brun-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.
- Background: PubMed 14501962Weycker 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.
- Background: PubMed 14501964Padkin 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.
- Background: PubMed 11907653Alberti 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.
- Background: PubMed 12700374Martin 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.
- Background: PubMed 11445675Angus 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.
- Individual participant dataSharing planned: Undecided. The decision regarding the sharing of individual participant data has not yet been finalized. IPD availability will depend on ethical approvals, institutional policies, and data-governance requirements across participating sites.
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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.
Ignacio-Martin Loeches, MD, PhD, FJFICMI contact
Ignacio-Martin Loeches, MD, PhD, FJFICMI principal investigator
St James' Hospital. Dublin, Ireland
Jean-Louis Vincent, MD, PhD principal investigator
Erasme University Hospital. Brussels, Belgium
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infection, run by Universidad de la Sabana.
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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Felipe Reyes, MD, MSc, PhD (+57 317 5130128, luis.reyes5@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at hospital discharge (time frame: Up to 60 days after the study day). 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 NCT07309549, which also lists 10 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 29 Jun 2026.