Prevalence of Multidrug-Resistant Organism Infections in General Adult Wards in Argentina (PREV-AR 2 - IGA)

NCT07797569 | Active Not Recruiting DMC

• 1 other identifier: 7722
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multidrug-Resistant Organism Infection; Healthcare-Associated Infections (HAIs); Antimicrobial Resistance (AMR)

Keywords

Multidrug-resistant organisms; Antimicrobial resistance; Prevalence; Healthcare-associated infection; General adult ward; Hospital mortality; Carbapenem resistance

Outcome Measures

Primary Outcomes (1)

• 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).

  Single day, within the study window of August 4-6, 2026

Secondary Outcomes (8)

• 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

• Distribution of MDRO type and resistance mechanism by infection site

  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)

Study Arms (1)

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.

Other: Observational data collection (chart review / point-prevalence survey)

Interventions

Observational data collection (chart review / point-prevalence survey) OTHER

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.

Adult patients hospitalized in general medical/surgical wards (IGA)

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases): collaborator
• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

CABA, Buenos Aires F.D., 1199, Argentina

Location

Related Publications (5)

• Balbuena JP, Cordova E, Mykietiuk A, Farina J, Ganete M, Scapellato P, Lespada MI, Nannini E, Contreras R, Cunto E, Barcelona L, Pasteran F, Salgueira C, Hojman M, Blanco M, Lopez Alegre H, Cox Fernandez WE, Ezcurra C, Godoy D, Biglia MA, Lopez Furst MJ, Mendez GA, Aguirre Rios MF, Messina O, Ciappina A, Palizas F, Altclas J, Gaudenzi G, Cardone R, Sanchez Cunto M, Ruiz M, Perez G, Sanchez C, Stryjewski ME. Carbapenem-Resistant Gram-Negative Bacilli Bacteremia in Argentina (EMBARCAR): Findings From a Prospective, Multicenter Cohort Study. Clin Infect Dis. 2025 Dec 24;81(5):879-888. doi: 10.1093/cid/ciaf259.

  PMID: 40393137 BACKGROUND

• Ciapponi A, Bardach A, Sandoval MM, Palermo MC, Navarro E, Espinal C, Quiros R. Systematic Review and Meta-analysis of Deaths Attributable to Antimicrobial Resistance, Latin America. Emerg Infect Dis. 2023 Nov;29(11):2335-2344. doi: 10.3201/eid2911.230753.

  PMID: 37877573 BACKGROUND

• GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16.

  PMID: 39299261 BACKGROUND

• Cornistein W, Balasini C, Nuccetelli Y, Rodriguez VM, Cudmani N, Roca MV, Sadino G, Brizuela M, Fernandez A, Gonzalez S, Aguila D, Macchi A, Staneloni MI, Estenssoro E. Prevalence and Associated Mortality of Infections by Multidrug-Resistant Organisms in Pediatric Intensive Care Units in Argentina (PREV-AR-P). Antibiotics (Basel). 2025 May 11;14(5):493. doi: 10.3390/antibiotics14050493.

  PMID: 40426558 BACKGROUND

• Cornistein W, Balasini C, Nuccetelli Y, Rodriguez VM, Cudmani N, Roca MV, Sadino G, Brizuela M, Fernandez A, Gonzalez S, Aguila D, Macchi A, Staneloni MI, Estenssoro E; Prevar Study Group. Prevalence and mortality associated with multidrug-resistant infections in adult intensive care units in Argentina (PREV-AR). Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0142624. doi: 10.1128/aac.01426-24. Epub 2025 Jan 22.

  PMID: 39840911 BACKGROUND

Related Links

• ENPIHA 2019 institutional report (Instituto Nacional de Epidemiología / VIHDA) - a government report, not indexed in PubMed

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 1, 2026
• Study Start: August 4, 2026
• Primary Completion: August 6, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)