An observational study in Multidrug-Resistant Organism Infection, Healthcare-Associated Infections (HAIs) and Antimicrobial Resistance (AMR), sponsored by Hospital Italiano de Buenos Aires. Active, not recruiting at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Hospital Italiano de Buenos Aires · Observational
This study measures how common infections caused by multidrug-resistant organisms (MDROs) are among adult patients hospitalized in general medical and surgical wards in Argentina, and how these infections relate to in-hospital death.
Background: A 2019 national survey (ENPIHA 2019), conducted across 255 hospital units in Argentina, found that nearly 29% of hospitalized patients had a healthcare-associated infection, most often caused by Klebsiella pneumoniae, Acinetobacter species, Pseudomonas aeruginosa, E. coli, and Staphylococcus aureus. Most prior regional studies combined data from intensive care and general ward patients together, making it hard to know how much of this burden specifically affects general medical/surgical wards. This study is designed to answer that question directly.
On a single day chosen by each hospital between August 4 and 6, 2026, doctors and infection-control staff at participating hospitals across Argentina will record information about every adult patient (18 years or older) who has been in a general adult ward for at least 24 hours. For each patient, the study team records basic demographics, underlying health conditions, whether the patient has an active infection that day, the site and type of that infection, the organism responsible, whether that organism is drug-resistant, and what antibiotics are being used. No study procedures, tests, or treatments are performed - the study only records information that is already part of routine hospital care.
Each patient is then followed for up to 60 days after the study day, using existing hospital records, to determine whether they were discharged alive or died in the hospital. No patient names or other identifying information are collected; each patient is assigned a code known only to the local site investigator.
This study is sponsored by the Sociedad Argentina de Infectología (SADI), in collaboration with the Sociedad Argentina de Terapia Intensiva (SATI) and the Sociedad Argentina de Medicina (SAM), with no external funding. It is one component of a larger multi-part project, PREV-AR 2, which separately surveys neonatal intensive care units and adult intensive care units at other points in 2026. This registration covers only the general adult ward (Internación General de Adultos, IGA) component.
Background and rationale The 2019 National Healthcare-Associated Infection Prevalence Study (ENPIHA 2019), conducted by Argentina's National Institute of Epidemiology across 255 units in 140 healthcare institutions, found an overall healthcare-associated infection (HAI) rate of 28.80%, with Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus as the leading pathogens. Regional literature on non-critical (general ward) inpatient populations remains limited, as most existing studies pool data from critical and non-critical care areas together, which obscures the true prevalence, predominant resistance phenotypes, and mortality impact specific to general internal medicine wards. Available evidence nonetheless suggests that infections caused by multidrug-resistant organisms (MDROs) are associated with substantially higher mortality - one recent analysis found an unadjusted MDRO-related mortality rate of 45%, with an adjusted risk of death 1.93 times higher than for infections caused by non-resistant organisms, an effect that is further amplified when empirical antibiotic treatment is inadequate.
PREV-AR 2 was designed to close this evidence gap by generating Argentina-specific, ward-level data on MDRO prevalence and its association with mortality, with the goal of informing infection prevention and control strategies, antimicrobial stewardship programs, and resource allocation (e.g., availability of appropriate antibiotics for MDRO treatment). Periodic, standardized prevalence measurement also creates a comparable baseline over time, enabling trend surveillance and future evaluation of the impact of prevention interventions.
Study objectives General objective: To estimate the prevalence of, and factors associated with, MDRO infection among adult patients hospitalized in general medical/surgical wards (IGA) in healthcare institutions across Argentina.
Specific objectives:
To calculate in-hospital mortality at day 28 and identify its independent predictors.
To identify risk factors associated with MDRO infection. To characterize infections by microbiological isolate, resistance mechanism (MDRO vs. non-MDRO), and site of infection.
To compare patients with and without MDRO infection with respect to risk factors, mortality, and length of hospital stay.
To describe the overall prevalence of infection (MDRO and non-MDRO) in this population.
Study population Target population: All patients hospitalized in general adult wards (IGA) in Argentine hospitals during the study period.
Accessible population: All patients hospitalized in the participating unit at the time of the study cut, at sites that agree to participate.
Unit of analysis: Each patient hospitalized in the surveyed unit on the study day.
Data collected Data are captured on a structured case report form (CRF) with three sections: (1) institutional/unit-level characteristics, (2) patient demographics and study-day variables, and (3) follow-up data.
Patient-level variables include: age and sex; hospital and ward admission/discharge dates; admission type (medical or surgical); baseline severity via the McCabe classification (non-fatal, ultimately fatal, rapidly fatal within 1 month, unknown); comorbidities and risk factors (asthma/COPD, diabetes, obesity, alcohol use disorder, smoking, ischemic heart disease, chronic liver disease, chronic kidney disease, immunosuppressive treatment, bone marrow or solid-organ transplant, oncohematologic malignancy, chemotherapy in the prior 6 months, HIV, antibiotic use in the prior 3 months, hospitalization in the prior 6 months, and abdominal surgery); and prior MDRO colonization or infection within the previous 3 months.
For the study day itself, clinical status is classified as: no infection; active infection without sepsis; confirmed/probable sepsis; or septic shock (per Sepsis-3-type criteria: vasopressor requirement to maintain MAP ≥65 mmHg after adequate fluid resuscitation plus lactate >2 mmol/L). For patients with active infection, the CRF records the origin (community-acquired, hospital-acquired outside the ward, or hospital-acquired within the general ward, including patients transferred from a higher level of care), infection site/syndrome (e.g., community/hospital-acquired pneumonia, catheter-associated or community urinary tract infection, primary or CVC-associated bacteremia, surgical site infection, C. difficile diarrhea, skin/soft-tissue, cardiovascular, osteoarticular, gynecologic/obstetric, nosocomial meningitis, or infection without a clear source), culture results, and up to two isolated organisms per infection episode.
Organisms are classified as MDRO or non-MDRO according to the WHO priority pathogen list for antibiotic research and development: MDRO categories include carbapenem-resistant Acinetobacter baumannii (ABRC), difficult-to-treat Pseudomonas aeruginosa (DT-PAE, resistant to antipseudomonal cephalosporins, aztreonam, piperacillin-tazobactam, imipenem, meropenem, and fluoroquinolones simultaneously), carbapenem-resistant Enterobacterales (EPC), extended-spectrum beta-lactamase-producing Enterobacterales (E-BLEE), vancomycin-resistant Enterococcus faecium (EVR), methicillin-resistant Staphylococcus aureus (MRSA), and S. aureus with intermediate (VISA) or full (VRSA) vancomycin resistance, plus Stenotrophomonas maltophilia. Fungi, parasites, and viruses are excluded. Resistance mechanisms recorded for gram-negative MDROs include KPC, MBL, OXA, ESBL, and combinations thereof. Antibiotic treatment is classified as empirical vs. targeted, traditional vs. novel agent (e.g., ceftazidime-avibactam, ceftolozane-tazobactam, imipenem-relebactam, aztreonam-avibactam), and by WHO AWaRe category (Access, Watch, Reserve).
Primary and secondary outcome measures Primary outcomes: (1) Prevalence of MDRO infection, calculated as the number of patients with active MDRO infection divided by the total number of patients hospitalized in the surveyed unit on the study day, ×100; (2) In-hospital mortality at day 28.
Secondary outcomes: Overall infection prevalence (MDRO and non-MDRO); distribution of infection sites and causative organisms; distribution of MDRO type and resistance mechanism by infection site; and comparison of risk factors, mortality, and length of hospital stay between patients with and without MDRO infection.
Adult patients (≥18 years) hospitalized in general medical/surgical wards of public, social-security, and private hospitals across Argentina that agreed to participate in the study, present in the ward for at least 24 hours before the designated single-day prevalence assessment (August 4-6, 2026). The accessible population includes all such patients at participating sites; no additional selection or exclusion based on diagnosis, infection status, or clinical severity was applied - the cohort captures the full spectrum of general ward patients, whether or not they have an active infection.
Exclusion Criteria:
All patients ≥18 years of age hospitalized in a general adult ward (Internación General de Adultos) for at least 24 hours prior to 8:00 AM local time on the study's designated prevalence day (August 4-6, 2026) at a participating Argentine hospital. Patients are followed using existing hospital records for up to 60 days after the study day to ascertain discharge status and in-hospital mortality. No study-specific intervention, treatment, or procedure is applied; all data reflect routine clinical care.
Other: Observational data collection (chart review / point-prevalence survey)
No study-specific intervention, treatment, diagnostic test, or procedure is performed. Investigators record data already generated through routine clinical and microbiological care (e.g., existing culture results, clinical status, comorbidities) using a structured case report form on a single prevalence day, with passive follow-up via hospital records for up to 60 days.
Prevalence of infection by multidrug-resistant organisms (MDRO)
Number of patients with an active MDRO infection on the study day, divided by the total number of patients hospitalized in the general adult ward (IGA) on that day, multiplied by 100. MDROs are defined per the WHO priority pathogen list (carbapenem-resistant Acinetobacter baumannii, difficult-to-treat Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales, extended-spectrum beta-lactamase-producing Enterobacterales, vancomycin-resistant Enterococcus faecium, methicillin-resistant/VISA/VRSA Staphylococcus aureus, and Stenotrophomonas maltophilia).
Time frame: Single day, within the study window of August 4-6, 2026
In-hospital mortality
Proportion of enrolled patients who die in-hospital within 28 days of the prevalence study day, ascertained through review of existing hospital records. Patients discharged alive before day 28 are classified as survivors; patients still hospitalized at day 28 are followed to that time point for vital status.
Time frame: Up to 28 days after the prevalence study day
Overall prevalence of infection (MDRO and non-MDRO combined)
Number of patients with any active infection (regardless of resistance profile) on the study day, divided by total patients hospitalized in the ward that day, multiplied by 100.
Time frame: Single day, within the study window of August 4-6, 2026
Distribution of infection sites and causative organisms
Frequency distribution of infection sites/syndromes (e.g., pneumonia, urinary tract infection, bacteremia, surgical site infection, skin/soft-tissue infection, among others) and of the microorganisms isolated in each active infection episode.
Time frame: Single day, within the study window of August 4-6, 2026
Distribution of MDRO type and resistance mechanism by infection site
Among patients with confirmed MDRO infection, frequency of each MDRO category (e.g., carbapenem-resistant Enterobacterales, MRSA, VRE) and underlying resistance mechanism (KPC, MBL, OXA, ESBL, or combinations), stratified by infection site.
Time frame: Single day, within the study window of August 4-6, 2026
Comorbidities and risk factors in patients with vs. without MDRO infection
Proportion of patients with each baseline comorbidity/risk factor (e.g., immunosuppression, chronic liver disease, oncohematologic malignancy, diabetes, prior MDRO colonization), compared between the subgroup with confirmed active MDRO infection and the subgroup without, using chi-square or Fisher's exact test.
Time frame: Baseline (data collected as of the study day)
Vital and discharge status at 60 days
Final status of each patient at 60 days after the study day, classified as: discharged alive (with discharge date), deceased in-hospital (with date of death), or still hospitalized (censored and classified as a survivor for analysis purposes, per protocol). Captures outcomes beyond the day-28 primary mortality window, including cases with prolonged hospitalization.
Time frame: Up to 60 days after the prevalence study day
28-day in-hospital mortality in patients with vs. without MDRO infection
Proportion of patients who die in-hospital within 28 days, compared between the subgroup with confirmed active MDRO infection and the subgroup without, using chi-square or Fisher's exact test.
Time frame: Up to 28 days after the prevalence study day
Length of hospital stay in patients with vs. without MDRO infection
Total length of hospital stay, in days, compared between the subgroup with confirmed active MDRO infection and the subgroup without, using Student's t-test or Wilcoxon rank-sum test as appropriate.
Time frame: From the study day through hospital discharge, death, or 60-day censoring, whichever comes first
Plan to share: No
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