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Multidrug-Resistant Organism InfectionPREVAR 2-IGANCT07797569

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

An observational study of Multidrug-Resistant Organism Infection and Healthcare-Associated Infections (HAIs), run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observational data collection (chart review / point-prevalence survey)
How many people
2,000 participants
Where
1 siteArgentina
Study dates
4 Aug 2026to 5 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Italiano de Buenos Aires

    CABA, Buenos Aires F.D., 1199

Other trials in Argentina

About this study

Official title: Prevalence and Mortality Study of Multidrug-Resistant Organism Healthcare-Associated Infections in General Adult Wards in Argentina (PREV-AR 2)

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.

Read more

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.

Read the detailed description
  1. 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. 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.
  3. Study design This is a multicenter, observational, analytical, cross-sectional prevalence study with prospective longitudinal follow-up for in-hospital mortality, conducted in public, social-security, and private-sector hospitals throughout Argentina. For the general adult ward (IGA) component, each participating site selects a single 24-hour data-collection window (beginning 8:00 AM local time) within August 4-6, 2026. Sampling is consecutive and non-probabilistic: all patients who have been hospitalized in a general adult ward for at least 24 hours before 8:00 AM on the chosen day are included. No intervention of any kind is performed, and no predefined sample size was set, as the design is a census-style prevalence cut rather than a hypothesis-driven comparison - the goal is to include as many eligible patients as possible.
  4. Setting and eligible sites Eligible hospitals must (a) sign an institutional commitment letter guaranteeing data collection support throughout the study, and (b) have on-site microbiology laboratory capability to detect antimicrobial resistance mechanisms using phenotypic, molecular, and/or immunochromatographic methods. Sites are recruited through SADI, SATI, and SAM via direct member outreach and public announcements. Institution-level data collected include hospital type (public/private/community/social-security), total and ward-level bed capacity, presence of an infection control committee, presence of an antimicrobial stewardship program (PROA), reporting to Argentina's national HAI surveillance system (VIHDA), and MDRO colonization-surveillance practices and methodology.
  5. 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.
  6. 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).
  7. Follow-up and outcome ascertainment Each patient is followed through existing hospital records until hospital discharge, transfer, or death. Data are censored 60 days after the prevalence cut date; patients still hospitalized at that point are classified as survivors for analysis. In-hospital mortality at day 28 is a co-primary outcome, together with the discharge date and vital status at discharge (alive or deceased, with date of death if applicable).
  8. 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.
  9. Data management and quality control Data are entered into REDCap (Research Electronic Data Capture), a validated platform for multicenter research, with built-in range, format, and mandatory-field validation to reduce transcription errors. All site investigators and coordinators complete mandatory centralized training on the CRF and REDCap use, including practice data entry with simulated ("dummy") patient cases, prior to study initiation. A SADI-appointed study coordinator performs active monitoring of the database to identify logical inconsistencies (e.g., a patient coded with sepsis but no documented infection source, or atypical severity scores) and issues data queries to local investigators for timely resolution. Missing data are categorized as missing-by-design versus missing-by-omission; multiple imputation may be applied to key variables in the final statistical analysis if deemed appropriate, with full documentation in the statistical analysis section of the final report. Data access is role-based and site-specific; patients are identified only by an internally generated code (initials-based), and no direct identifiers (name, national ID, or medical record number) are transmitted to the coordinating data center at any point.
  10. Statistical analysis As this is a no-risk observational study with no predefined sample size, the analysis includes all patients enrolled. Prevalence is calculated as described above. Categorical variables are summarized as absolute numbers and percentages; continuous variables as means with standard deviations or medians with interquartile ranges [P25-P75], depending on distribution normality. Between-group comparisons use the chi-square or Fisher's exact test for categorical variables, and Student's t-test or Wilcoxon rank-sum test for continuous variables. A two-tailed p-value <0.05 is considered statistically significant, with Bonferroni correction applied for multiple comparisons where appropriate.
  11. Ethics The study was granted a waiver of individual informed consent by participating institutional ethics/research committees, based on its non-interventional, no-risk, descriptive design and the use of fully de-identified, code-based data. Conduct of the study follows the Declaration of Helsinki and applicable Argentine national regulations (Resolución 1480/11, Ministerio de Salud de la Nación; Disposición 6677/10, ANMAT).
  12. Relationship to the broader PREV-AR 2 project This registration corresponds specifically to the general adult ward (Internación General de Adultos, IGA) component of PREV-AR 2, a national multi-society project (SADI, SATI, SAM) that separately conducts prevalence cuts in neonatal intensive care units (April 8-9, 2026) and adult intensive care units (November 25-27, 2026), each registered and analyzed independently.
Being tested
Observational data collection (chart review / point-prevalence survey)
Keywords
Multidrug-resistant organisms, Antimicrobial resistance, Prevalence, Healthcare-associated infection, General adult ward, Hospital mortality, Carbapenem resistance
Medical subject headings
Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07797569
Study groupRoleWhat they receive
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.
Receives: Other: Observational data collection (chart review / point-prevalence survey)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (8)

  1. 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.

    Measured: Up to 28 days after the prevalence study day

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: Baseline (data collected as of the study day)

  6. 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.

    Measured: Up to 60 days after the prevalence study day

  7. 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.

    Measured: Up to 28 days after the prevalence study day

  8. 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.

    Measured: From the study day through hospital discharge, death, or 60-day censoring, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study start4 Aug 2026
  3. Primary completion6 Aug 2026
  4. Study completion5 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07797569
Sponsor's protocol ID
7722
Acronym
PREVAR 2-IGA
Status last verified
Aug 2026
First submitted
26 Aug 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40393137

  • 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.

    PubMed 37877573

  • 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.

    PubMed 39299261

  • 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.

    PubMed 40426558

  • 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.

    PubMed 39840911

Questions about this trial

What is this clinical trial studying?

An observational study of Multidrug-Resistant Organism Infection and Healthcare-Associated Infections (HAIs), run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of infection by multidrug-resistant organisms (MDRO) (time frame: Single day, within the study window of August 4-6, 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07797569, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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