NCT07397416

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Carbapenemase-producing Enterobacterales (CPE) are critical-priority pathogens associated with increased morbidity, mortality, and healthcare costs. Screening and isolation are recommended infection control measures, yet delays inherent to culture-based methods can hinder timely decision-making and overuse limited isolation rooms. Objective: To compare the time to initiation and discontinuation of contact isolation-from swab request to result availability and isolation status update-before and after implementing a rapid PCR-based diagnostic protocol for CPE identification. Design and Setting: Retrospective, quasi-experimental before-after study at the Hospital Italiano de Buenos Aires, Argentina. The pre-intervention period covers October 1, 2023-April 30, 2024; the post-intervention period covers October 1, 2024-April 30, 2025. Intervention: Incorporation of real-time PCR testing (BD MAX™ System) for CPE genes (bla\_KPC, bla\_NDM, bla\_VIM/IMP, bla\_OXA-48-like) into the existing CPE surveillance and isolation reevaluation workflow. The infection control team coordinates sample requests and response actions. Primary Outcomes: Time difference (in hours) from surveillance swab request to isolation implementation. Time difference (in hours) from surveillance swab request to isolation discontinuation. Secondary Outcomes: Time differences stratified by weekday versus weekend. Time differences according to sampling time (08:00-16:00 vs 16:00-08:00). Time differences according to immunosuppression status. Time differences in ICU versus general ward settings. Data Collection: Four timestamps will be extracted from the electronic health record (EHR): swab request, laboratory check-in, final laboratory result, and change in isolation logo. These will allow computation of operational intervals (request → action), collection delay, processing delay, and action delay. Statistical Analysis: Continuous variables will be summarized as medians and interquartile ranges. Median time differences between pre- and post-intervention periods will be compared using mixed-effects linear regression adjusted for immunosuppression, ICU admission, day of the week, and public holidays. Analyses will be conducted using Stata v16. Ethical Considerations: The study is retrospective and minimal-risk, involving only secondary use of clinical data. It has been submitted to the CEPI (Comité de Ética de Protocolos de Investigación), Hospital Italiano de Buenos Aires (PRIISA 15728), with waiver of informed consent under CIOMS 2019 Guideline 10. Expected Impact: By quantifying real-time process improvements after PCR implementation, this study will provide evidence on diagnostic turnaround times and operational efficiency in infection control practices.

Conditions

• Carbapenemase-Producing Enterobacterales (CPE) Colonization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2026-02-09
• Last updated: 2026-02-09