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

ConditionCarbapenemase-Producing Enterobacterales (CPE) Colonization
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Rapid PCR-based algorithm for CPE detection

    Diagnostic test

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Pre-intervention periodNo intervention 0 interventions
Group B: Post-intervention periodActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from surveillance swab request to isolation implementation or discontinuation (hours)

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

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).

Secondary outcomes

1

Sample collection delay (hours)

Description: Time elapsed between the electronic request for perianal surveillance swab and laboratory check-in of the sample. Unit of Measure: 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.
2

Laboratory processing delay (hours)

Time elapsed between laboratory check-in of the perianal swab sample and availability of the final laboratory result. Unit of Measure: 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.
3

Action delay after laboratory result (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

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Italiano de Buenos Aires

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: