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NCT Number: NCT07309549

The Extended Study of Prevalence of Infection in Intensive Care 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.

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Key information

Conditions

Sepsis Critical Illness Disease Attributes Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients under 18 years

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio-Martin Loeches, MD, PhD, FJFICMI

CONTACT

[email protected]

Luis Felipe Reyes, MD, MSc, PhD

CONTACT

[email protected]

+57 317 5130128

Sponsors and collaborators

Lead sponsor

Universidad de la Sabana

Other

Registry information

Official study title

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

Acronym: EPIC IV

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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