Impact of Implementing a Rapid PCR-based Algorithm for Carbapenemase-producing Enterobacterales (… (NCT07397416) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Implementing a Rapid PCR-based Algorithm for Carbapenemase-producing Enterobacterales (CPE) and Infection Control Bundle in a Tertiary Hospital
800 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time from surveillance swab request to isolation implementation or discontinuation (hours)
Timeframe: 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).