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

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.

NCT Number	NCT07397416
Lead Sponsor	Hospital Italiano de Buenos Aires
Conditions	Carbapenemase-Producing Enterobacterales (CPE) Colonization
Enrollment	800 participants
Start Date	2026-03-01
Primary Completion	2026-04-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-09