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

February 4, 2026 updated by: EMILIO FELIPE HUAIER ARRIAZU, Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

  • Patients with indication for active surveillance at hospital admission:

    • Transfer from another healthcare facility
    • Hospitalization in another healthcare center within the previous month

  • Patients undergoing active surveillance during hospitalization:

    • First surveillance swab in high-risk neutropenic patients (HAR flag)
    • First surveillance swab in immunosuppressed units, such as hematopoietic stem-cell transplant wards

  • Patients evaluated for discontinuation of contact precautions who meet all of the following:

    • Prior CPE-positive surveillance sample
    • At least 3 months since the last positive result and last hospitalization
    • No systemic antibiotic exposure during that period

Exclusion Criteria:

  • Lost samples
  • Insufficient samples
  • Invalid laboratory test results requiring repeat sampling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-intervention period
The baseline phase preceding the implementation of the rapid PCR-based algorithm. During this period, the institutional workflow for carbapenemase-producing Enterobacterales (CPE) surveillance and isolation reevaluation relied exclusively on culture-based methods. Patients evaluated for CPE carriage or decolonization were tested using CHROMagar™ KPC and phenotypic confirmation methods (including MALDI-TOF and NG-Test CARBA 5 when indicated). Discontinuation of isolation required either three negative cultures or two negative cultures plus one PCR performed at least three months after the last positive result. No modification of staffing, alert systems, or isolation criteria occurred during this period.
Active Comparator: Post-intervention period
The implementation phase beginning November 6, 2024, when the rapid PCR-based diagnostic algorithm for carbapenemase-producing Enterobacterales (CPE) was incorporated into the existing infection control workflow. Real-time PCR was performed using the BD MAX™ System to detect bla_KPC, bla_NDM, bla_VIM/IMP, and bla_OXA-48-like genes directly from rectal swabs. The infection control team coordinated sample requests, result communication, and isolation/de-isolation actions. The new algorithm prioritized PCR testing for surveillance and discontinuation of isolation in patients not receiving antibiotics, replacing culture-based testing in those scenarios.
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.
Other Names:
  • Rapid molecular diagnostic algorithm for CPE; BD MAX CPE PCR workflow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from surveillance swab request to isolation implementation or discontinuation (hours)
Time Frame: From the date and time of electronic request for perianal swab collection until the date and time of isolation status update in the EHR, assessed up to 168 hours (7 days).

Primary Outcome Measure

1. Operational time from surveillance swab request to isolation status change (hours)

Description:

Time elapsed between the electronic request for perianal surveillance swab (clinical suspicion) and the implementation or discontinuation of the carbapenemase-producing Enterobacterales (EPC) isolation logo in the electronic health record (EHR).

Unit of Measure: Hours
From the date and time of electronic request for perianal swab collection until the date and time of isolation status update in the EHR, assessed up to 168 hours (7 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sample collection delay (hours)
Time Frame: From the date and time of electronic request for perianal swab collection until laboratory check-in of the sample, assessed up to 72 hours.

Description:

Time elapsed between the electronic request for perianal surveillance swab and laboratory check-in of the sample.

Unit of Measure: Hours
From the date and time of electronic request for perianal swab collection until laboratory check-in of the sample, assessed up to 72 hours.
Laboratory processing delay (hours)
Time Frame: From the date and time of laboratory check-in until the date and time of final laboratory result, assessed up to 96 hours.

Time elapsed between laboratory check-in of the perianal swab sample and availability of the final laboratory result.

Unit of Measure: Hours
From the date and time of laboratory check-in until the date and time of final laboratory result, assessed up to 96 hours.
Action delay after laboratory result (hours)
Time Frame: From the date and time of final laboratory result until the date and time of isolation status update in the EHR, assessed up to 72 hours.

Time elapsed between availability of the final laboratory result and update of the EPC isolation status (logo) in the electronic health record.

Unit of Measure: Hours
From the date and time of final laboratory result until the date and time of isolation status update in the EHR, assessed up to 72 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPI No. 7443 PRIISA 15728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data derived from institutional electronic health records cannot be shared externally due to confidentiality agreements and national data protection laws (Law 25.326, Argentina). Aggregated results will be available upon publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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