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NOT YET RECRUITING
NCT07397416
NA

Impact of Implementing a Rapid PCR-based Algorithm for Carbapenemase-producing Enterobacterales (CPE) and Infection Control Bundle in a Tertiary Hospital

Sponsor: Hospital Italiano de Buenos Aires

View on ClinicalTrials.gov

Summary

Purpose: Carbapenemase-producing Enterobacterales (CPE) are a growing cause of healthcare-associated infections, linked to high morbidity, mortality, and cost. Current screening methods rely mainly on culture, which can take up to 48 hours and delay infection control actions. This study aims to evaluate the real-life impact of implementing a rapid PCR-based algorithm for CPE detection compared with the standard culture-based protocol, focusing on time differences in isolation and de-isolation decisions in hospitalized patients. Design: A quasi-experimental, before-and-after, retrospective study conducted at Hospital Italiano de Buenos Aires (HIBA). Primary Outcome: Time (in hours) between rectal swab request and change in isolation status (application or removal of isolation label) before and after PCR implementation. Population: Adult patients (≥18 years) admitted between October 2023-April 2024 (pre-intervention) and October 2024-April 2025 (post-intervention), who had contact isolation initiated or discontinued based on CPE surveillance results. Rationale: The introduction of rapid molecular testing could reduce operational delays and unnecessary isolation days, optimizing resource use in a setting with high CPE endemicity.

Official title: Intervention in the CPE Surveillance Algorithm and Isolation Re-evaluation With the Addition of PCR vs. Culture-based Protocol: Real-life Time Differences

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-03-01

Completion Date

2026-05-01

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Rapid PCR-based algorithm for CPE detection

Implementation of a rapid real-time PCR-based diagnostic algorithm for the detection of carbapenemase-producing Enterobacterales (CPE) integrated into the institutional infection control workflow. The BD MAX™ System detects bla\_KPC, bla\_NDM, bla\_VIM/IMP, and bla\_OXA-48-like genes from rectal swabs. The infection control team manages the process from sample request to result-based isolation decision. The intervention began on November 6, 2024, upon availability of PCR supplies and reagents.