Predictive Model for Multidrug Resistance in Patients Admitted to the Emergency Department With Sepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Italiano de Buenos Aires
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
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.
Disqualifiers
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.
Trial population
Individuals aged 18 years or older with sepsis.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Individuals with sepsis
Trial outcomes
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
Time frame
Baseline (within the first 48 hours of admission)Secondary outcomes
1
Culture positivity
Dichotomous variable. It will be considered positive or negative.
Time frame
Baseline2
Bacterial species (Number of Participants with each microorganism species)
Categorical variable; the following will be considered: Escherichia coli, Salmonella, Shigella, Klebsiella pneumoniae, Proteus mirabilis, other Proteus species (P. penneri or P. vulgaris), Morganella morganii, Providencia stuartii, Providencia rettgeri, Serratia marcescens, Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Klebsiella aerogenes, Hafnia alvei, Pseudomonas aeruginosa, Acinetobacter baumannii, Stenotrophomonas maltophilia, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, coagulase-negative Staphylococcus, Streptococcus pneumoniae, group A beta-hemolytic Streptococcus, Streptococcus pyogenes, Haemophilus influenzae, Neisseria meningitidis, Listeria monocytogenes, others.
Time frame
Baseline3
Enzymatic resistance mechanisms (Number of Participants with each enzymatic mechanism detected)
Categorical variable, the following will be considered: No enzymatic mechanism; MRSA; VRE; KPC; MBL; OXA.
Time frame
Baseline4
Carbapenemase genotypes (Number of participants with each genotypic resistance mechanism -KPC, NDM, VIM, OXA-48, IMP- detected by multiplex PCR assay)
Categorical variable; the following will be considered: Types of carbapenemases if studied (for example, KPC, NDM, VIM, IMP, OXA-48 like).
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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