NCT06574776

Brief Summary

Observational 24-hr point prevalence study with longitudinal follow-up at 164 ICUs in Argentina. All adult patients (aged ≥18 years) at a participating ICU on November 24-28, 2023 with 60- day follow-up, were included. Epidemiological variables, sites of infection, isolated microorganisms, CPE colonisation, and hospital characteristics were collected. Main outcome measure was ICU mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,799

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

4 days

First QC Date

August 23, 2024

Last Update Submit

August 26, 2024

Conditions

Infectious Disease

Keywords

antimicrobial resistancecritical care

Outcome Measures

Primary Outcomes (1)

  • prevalence of infection by MDRO

    The main outcome measure was the prevalence of infection by MDRO.

    All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.

Secondary Outcomes (3)

  • ICU mortality

    28 days

  • prevalence of colonisation by MDRO

    All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.

  • prevalence of infection in general

    All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.

Study Arms (1)

A single cohort

It is a study with a single cohort.

Other: Observation and collecting data

Interventions

Observation and collecting dataOTHER

In that single cohort we will collect data on MDRO infection and colonization prevalence, clinical characteristics, infections, causative organisms and mortality.

A single cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The exact date could be selected from November 24-28, 2023, to ease logistics for individual sites. The patients present on day 1 in the ICU were available for inclusion in the cohort, which was then followed for mortality.

You may qualify if:

  • All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Austral

Buenos Aires, Argentina

Location

Hospital de San Martin de La Plata

Buenos Aires, Argentina

Location

Hospital Italiano

Buenos Aires, Argentina

Location

Hospital Pirovano

Buenos Aires, Argentina

Location

Hospital Tornu

Buenos Aires, Argentina

Location

Sanatorio Las Lomas

Buenos Aires, Argentina

Location

Hospital de Clínicas Pte Nicolás Avellaneda

San Miguel de Tucumán, Argentina

Location

Related Publications (1)

  • 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: 39840911DERIVED

MeSH Terms

Conditions

Communicable Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Maria I Staneloni, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 28, 2024

Study Start

November 24, 2023

Primary Completion

November 28, 2023

Study Completion

January 24, 2024

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations

AR(7)