The Extended Study of Prevalence of Infection in Intensive Care IV (EPIC IV)

December 15, 2025 updated by: Universidad de la Sabana

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients under 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
All patients present on or admitted to a contributing ICU on the study day
None interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 60 days after the study day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: From ICU admission to ICU discharge (up to 60 days)
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.
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)
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.
From ICU/hospital admission to discharge (up to 60 days)
Organ Failure
Time Frame: From ICU/hospital admission to discharge (up to 60 days)
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.
From ICU/hospital admission to discharge (up to 60 days)
Antimicrobial Resistance
Time Frame: From ICU/hospital admission to discharge (up to 60 days)
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.
From ICU/hospital admission to discharge (up to 60 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de la Sabana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St. James's Hospital, Ireland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pending (Other Grant/Funding Number: American Acedemy of Optometry Foundation (AAOF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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