Prevalence and Mortality Study of Multidrug-Resistant Organism Healthcare-Associated Infections in General Adult Wards in Argentina (PREV-AR 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Prevalence of infection by multidrug-resistant organisms (MDRO)
研究概览
简要总结
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.
详细描述
- 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. 2. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Hospitalized in a general adult medical or surgical ward (Internación General de Adultos, IGA) at a participating institution
- •Hospitalized in the ward for at least 24 hours prior to 8:00 AM local time on the site's designated study day (within the window of August 4-6, 2026)
排除标准
- •Hospitalized in an area other than a general adult medical/surgical ward on the study day (e.g., intensive care unit, neonatal unit, pediatric ward)
- •Hospitalized in the ward for less than 24 hours prior to 8:00 AM local time on the study day
研究组 & 干预措施
Adult patients hospitalized in general medical/surgical wards (IGA)
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.
干预措施: Observational data collection (chart review / point-prevalence survey) (Other)
结局指标
主要结局
Prevalence of infection by multidrug-resistant organisms (MDRO)
时间窗: Single day, within the study window of August 4-6, 2026
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).
次要结局
- Distribution of MDRO type and resistance mechanism by infection site(Single day, within the study window of August 4-6, 2026)
- In-hospital mortality(Up to 28 days after the prevalence study day)
- Overall prevalence of infection (MDRO and non-MDRO combined)(Single day, within the study window of August 4-6, 2026)
- Distribution of infection sites and causative organisms(Single day, within the study window of August 4-6, 2026)
- Comorbidities and risk factors in patients with vs. without MDRO infection(Baseline (data collected as of the study day))
- Vital and discharge status at 60 days(Up to 60 days after the prevalence study day)
- 28-day in-hospital mortality in patients with vs. without MDRO infection(Up to 28 days after the prevalence study day)
- Length of hospital stay in patients with vs. without MDRO infection(From the study day through hospital discharge, death, or 60-day censoring, whichever comes first)
研究者
MARIA INES STANELONI
Principal Investigator
Hospital Italiano de Buenos Aires