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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Italiano de Buenos Aires

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients aged ≥18 years

Patients screened for carbapenemase-producing Enterobacterales (CPE) carriage by perianal swab within the first 5 days of hospital admission

Patients newly identified as CPE-colonized, leading to initiation of contact isolation

Patients found to be decolonized, leading to discontinuation of contact isolation

Disqualifiers

Lost samples

Insufficient samples

Invalid laboratory test results requiring repeat sampling

Trial design

Treatments tested in this trial

  • Rapid PCR-based algorithm for CPE detection

Treatment groups

800 Participants
are divided into 2 treatment groups

Locations

This trial has no locations