Predictive Model for Multidrug Resistance in Patients Admitted to the Emergency Department With Sepsis

NCT07167173 | Not Yet Recruiting

• 1 other identifier: 7441
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Timely and accurate antibiotic administration in emergency department (ED) patients with sepsis or septic shock is vital, given mortality rates of 20% and over 40%, respectively. In high antimicrobial resistance (AMR) settings, selecting effective empirical antibiotics is challenging, requiring a balance between efficacy and minimizing multidrug-resistant organism (MDRO) emergence. A predictive model estimating AMR probability could optimize antibiotic use, improve outcomes, and reduce resistance. Although risk factors are known, no single validated model exists for predicting multidrug resistance in sepsis. Accurate prediction must integrate patient history, pathogen profiles, infection source, and antibiotic characteristics. Objectives: To estimate AMR prevalence in adult ED patients with sepsis or septic shock and develop a validated predictive model estimating AMR probability and likely pathogens. The model will follow a three-phase approach: (1) predict culture positivity, (2) estimate pathogen likelihood, and (3) predict AMR. Additionally, we aim to describe individual-level statistics for both predictable and unpredictable cases based on model performance. Methods: A cross-sectional study will be conducted at Hospital Italiano's adult ED over 70 months (Jan 1, 2017-Mar 20, 2020 and May 1, 2022-Aug 10, 2025), excluding the COVID-19 period. Primary outcomes include culture positivity, bacterial species, and MDRO prevalence. Frequency analyses will use positive cultures, species, and resistance classifications (MDRO, MDR, XDR, PDR), including mechanisms (e.g., MRSA, ESBL, KPC, MBL, OXA). Denominators will include all sepsis patients and, separately, culture-positive cases. Confidence intervals (95%) will be calculated using normal approximation. Multivariate logistic regression with backward stepwise selection will identify predictors and interactions. A hierarchical model will be developed based on culture results, pathogen identification, and resistance profiles.

Conditions

Sepsis; Septic Shock

Keywords

Antimicrobial resistance; sepsis; predictive models

Outcome Measures

Primary Outcomes (1)

• Proportion of episodes with multidrug-resistant organisms (MDRO)

  Percentage of episodes with a positive bacterial culture that meet criteria for multidrug resistance (MDR or greater, i.e., MDR/XDR/PDR), defined according to Magiorakos et al., 2012. Unit of Measure: % of culture-positive episodes

  Baseline (within the first 48 hours of admission)

Secondary Outcomes (7)

• Culture positivity

  Baseline

• Bacterial species (Number of Participants with each microorganism species)

  Baseline

• Enzymatic resistance mechanisms (Number of Participants with each enzymatic mechanism detected)

  Baseline

• Carbapenemase genotypes (Number of participants with each genotypic resistance mechanism -KPC, NDM, VIM, OXA-48, IMP- detected by multiplex PCR assay)

  Baseline

• Proportion of episodes with MDR organisms

  Baseline

Study Arms (1)

Individuals with sepsis

Individuals aged 18 years or older who present to the Adult Emergency Department (CEA) at the Hospital Italiano de Buenos Aires between 01/01/2017 and 10/08/2025 with sepsis or septic shock and requiring at least 48 hours of observation or admission. The COVID-19 pandemic period will be excluded.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals aged 18 years or older with sepsis.

You may qualify if:

• Adults aged 18 years or older.
• Attended at the Adult Emergency Department of Hospital Italiano de Buenos Aires during the periods:
• January 1, 2017 - March 20, 2020, or
• May 1, 2022 - August 10, 2025.
• Sepsis or septic shock at presentation and at least 48 hours of observation or hospital admission.
• Bacterial cultures obtained during the initial evaluation.

You may not qualify if:

• No indication for antibiotic therapy within the first 48 hours of hospital admission.
• No bacterial cultures performed within the first 48 hours of hospital admission.
• SARS-CoV-2 infection diagnosed within the first 72 hours of hospital admission.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

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Related Links

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• References \& Sources. In: The UK Sepsis Trust \[Internet\]. 9 Aug 2024 \[cited 9 Mar 2025\]. Available: https://sepsistrust.org/about-sepsis/references-sources/
• Surviving Sepsis Campaign. In: Society of Critical Care Medicine (SCCM) \[Internet\]. \[cited 6 Apr 2025\]. Available: https://www.sccm.org/survivingsepsiscampaign
• Global antimicrobial resistance and use surveillance system (GLASS) report: 2022. World Health Organization; 9 Dec 2022 \[cited 3 Oct 2023\]. Available: https://www.who.int/publications/i/item/9789240062702
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MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Emilio Felipe H Huaier Arriazu, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio Felipe Huaier Arriazu, MD

CONTACT

+5491149590200; emilio.huaier@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious disease physician, member of the Infectious disease department and the Infection control committee of Hospital Italiano de Buenos Aires

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: September 11, 2025
• Study Start: October 15, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 31, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share