An interventional study of Rapid PCR-based algorithm for CPE detection in Carbapenemase-Producing Enterobacterales (CPE) Colonization, sponsored by Hospital Italiano de Buenos Aires. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Hospital Italiano de Buenos Aires · Not applicable, Interventional, and Diagnostic
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.
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.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 800 is above the median of 185 across 169 interventional studies indexed under Cross Infection.
Browse Cross Infection studies →Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with indication for active surveillance at hospital admission:
Patients undergoing active surveillance during hospitalization:
Patients evaluated for discontinuation of contact precautions who meet all of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Also known as: Rapid molecular diagnostic algorithm for CPE; BD MAX CPE PCR workflow
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).
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.
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.
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.
No study locations are listed for this record.
Plan to share: No — 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.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Italiano de Buenos Aires →