Carbapenemase-Producing Enterobacterales (CPE) ColonizationNCT07397416
Impact of Implementing a Rapid PCR-based Algorithm for Carbapenemase-producing Enterobacterales (CPE) and Infection Control Bundle in a Tertiary Hospital
A study testing Rapid PCR-based algorithm for CPE detection in people with Carbapenemase-Producing Enterobacterales (CPE) Colonization, run by Hospital Italiano de Buenos Aires.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenemase-Producing Enterobacterales (CPE) Colonization
- What is being tested?
- Rapid PCR-based algorithm for CPE detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Lost samples
- Insufficient samples
- Invalid laboratory test results requiring repeat sampling
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Emilio Felipe Huaier Arriazu, MD contact
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Rapid PCR-based algorithm for CPE detection
- Keywords
- Healthcare-Associated Infections, Antimicrobial Resistance, Enterobacteriaceae Infections, Nosocomial Colonization, Infection Control
- Medical subject headings
- Cross Infection, Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid PCR-based algorithm for CPE detectionDiagnostic test
Also called Rapid molecular diagnostic algorithm for CPE; BD MAX CPE PCR workflow
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention period | No intervention | 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. |
| Post-intervention period | Active comparator | 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. Receives: Diagnostic Test: Rapid PCR-based algorithm for CPE detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from surveillance swab request to isolation implementation or discontinuation (hours)
Primary Outcome Measure
- 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
Measured: 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 (3)
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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carbapenemase-Producing Enterobacterales (CPE) ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study follows a sequential, before-after interventional design. The same hospital population and inclusion criteria are applied in two consecutive periods: * Pre-intervention period: standard culture-based algorithm for carbapenemase-producing Enterobacterales (CPE) surveillance and isolation reevaluation. * Post-intervention period: implementation of a rapid PCR-based algorithm (BD MAX™ System) for CPE detection integrated into the same workflow. No randomization or masking is performed. The comparison evaluates real-life time differences in isolation and de-isolation processes before and after PCR implementation.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMILIO FELIPE HUAIER ARRIAZU, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397416
- Sponsor's protocol ID
- CEPI No. 7443 PRIISA 15728
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
van Duin D, Doi Y. The global epidemiology of carbapenemase-producing Enterobacteriaceae. Virulence. 2017 May 19;8(4):460-469. doi: 10.1080/21505594.2016.1222343. Epub 2016 Aug 11.
PubMed 27593176Orena BS, Liporace MF, Teri A, Girelli D, Salari F, Mutti M, Giordano G, Alteri C, Gentiloni Silverj F, Matinato C, Callegaro A, Cariani L. Active Surveillance of Patients Colonized with CRE: A Single-Center Study Based on a Combined Molecular/Culture Protocol. Antibiotics (Basel). 2024 Nov 6;13(11):1053. doi: 10.3390/antibiotics13111053.
PubMed 39596746Lim C, Ashley EA, Hamers RL, Turner P, Kesteman T, Akech S, Corso A, Mayxay M, Okeke IN, Limmathurotsakul D, van Doorn HR. Surveillance strategies using routine microbiology for antimicrobial resistance in low- and middle-income countries. Clin Microbiol Infect. 2021 Oct;27(10):1391-1399. doi: 10.1016/j.cmi.2021.05.037. Epub 2021 Jun 7.
PubMed 34111583Knight GM, Dyakova E, Mookerjee S, Davies F, Brannigan ET, Otter JA, Holmes AH. Fast and expensive (PCR) or cheap and slow (culture)? A mathematical modelling study to explore screening for carbapenem resistance in UK hospitals. BMC Med. 2018 Aug 16;16(1):141. doi: 10.1186/s12916-018-1117-4.
PubMed 30111322A C, N C, A S, A P, E Y, F G, M C. Validation of a rapid molecular detection test for gram-negative multidrug-resistant bacteria in rectal swabs upon admission of patients to the intensive care unit. Diagn Microbiol Infect Dis. 2024 Jun;109(2):116250. doi: 10.1016/j.diagmicrobio.2024.116250. Epub 2024 Mar 8.
PubMed 38479092Fasciana T, Antonelli A, Bianco G, Lombardo D, Codda G, Roscetto E, Perez M, Lipari D, Arrigo I, Galia E, Tricoli MR, Calvo M, Niccolai C, Morecchiato F, Errico G, Stefani S, Cavallo R, Marchese A, Catania MR, Ambretti S, Rossolini GM, Pantosti A, Palamara AT, Sabbatucci M, Serra N, Giammanco A. [The CCM Project "Phenotypic and molecular screening methodologies for the detection of coloniza-tions due to carbapenem-resistant Enterobacterales (CRE)"]. Epidemiol Prev. 2024 Nov-Dec;48(6):470-475. doi: 10.19191/EP24.6.A806.137. Italian.
PubMed 39679488Lydeamore MJ, Wu D, Donker T, Gorrie C, Higgs CK, Easton M, Hennessy D, Geard N, Howden BP, Cooper BS, Wilson A, Peleg AY, Stewardson AJ. Changes in isolation guidelines for CPE patients results in only mild reduction in required hospital beds. Infect Dis Health. 2025 May;30(2):128-131. doi: 10.1016/j.idh.2024.10.004. Epub 2024 Nov 24.
PubMed 39586760Jimenez A, Fennie K, Munoz-Price LS, Ibrahimou B, Pekovic V, Abbo LM, Martinez O, Rosello G, Sposato K, Doi Y, Trepka MJ. Duration of carbapenemase-producing Enterobacteriales carriage among ICU patients in Miami, FL: A retrospective cohort study. Am J Infect Control. 2021 Oct;49(10):1281-1286. doi: 10.1016/j.ajic.2021.06.006. Epub 2021 Jun 17.
PubMed 34146625Zimmerman FS, Assous MV, Bdolah-Abram T, Lachish T, Yinnon AM, Wiener-Well Y. Duration of carriage of carbapenem-resistant Enterobacteriaceae following hospital discharge. Am J Infect Control. 2013 Mar;41(3):190-4. doi: 10.1016/j.ajic.2012.09.020.
PubMed 23449280van Veen A, de Goeij I, Damen M, Huijskens EGW, Paltansing S, van Rijn M, Bentvelsen RG, Veenemans J, van der Linden M, Vos MC, Severin JA; Infection Prevention and Antimicrobial Resistance Care Network South-western Netherlands. Regional variation in the interpretation of contact precautions for multi-drug-resistant Gram-negative bacteria: a cross-sectional survey. J Hosp Infect. 2024 Oct;152:1-12. doi: 10.1016/j.jhin.2024.06.020. Epub 2024 Jul 26.
PubMed 39069006
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention in the CPE Surveillance Algorithm and Isolation Re-evaluation With the Addition of PCR vs. Culture-based Protocol: Real-life Time Differences
- ClinicalTrials.gov ID
- NCT07397416
- Acronym / sponsor ID
- CEPI No. 7443 PRIISA 15728
- Keywords
- Healthcare-Associated Infections, Antimicrobial Resistance, Enterobacteriaceae Infections, Nosocomial Colonization, Infection Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study follows a sequential, before-after interventional design. The same hospital population and inclusion criteria are applied in two consecutive periods: * Pre-intervention period: standard culture-based algorithm for carbapenemase-producing Enterobacterales (CPE) surveillance and isolation reevaluation. * Post-intervention period: implementation of a rapid PCR-based algorithm (BD MAX™ System) for CPE detection integrated into the same workflow. No randomization or masking is performed. The comparison evaluates real-life time differences in isolation and de-isolation processes before and after PCR implementation.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention period | No intervention | –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. |
| Post-intervention period | Active comparator | Diagnostic Test: Rapid PCR-based algorithm for CPE detectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (3 listed)
- Lost samples
- Insufficient samples
- Invalid laboratory test results requiring repeat sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid PCR-based algorithm for CPE detectionAlso: Rapid molecular diagnostic algorithm for CPE; BD MAX CPE PCR workflowImplementation 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. | Diagnostic test | Post-intervention period |
Primary outcome
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
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 27593176van Duin D, Doi Y. The global epidemiology of carbapenemase-producing Enterobacteriaceae. Virulence. 2017 May 19;8(4):460-469. doi: 10.1080/21505594.2016.1222343. Epub 2016 Aug 11.
- Results publication: PubMed 39596746Orena BS, Liporace MF, Teri A, Girelli D, Salari F, Mutti M, Giordano G, Alteri C, Gentiloni Silverj F, Matinato C, Callegaro A, Cariani L. Active Surveillance of Patients Colonized with CRE: A Single-Center Study Based on a Combined Molecular/Culture Protocol. Antibiotics (Basel). 2024 Nov 6;13(11):1053. doi: 10.3390/antibiotics13111053.
- Results publication: PubMed 34111583Lim C, Ashley EA, Hamers RL, Turner P, Kesteman T, Akech S, Corso A, Mayxay M, Okeke IN, Limmathurotsakul D, van Doorn HR. Surveillance strategies using routine microbiology for antimicrobial resistance in low- and middle-income countries. Clin Microbiol Infect. 2021 Oct;27(10):1391-1399. doi: 10.1016/j.cmi.2021.05.037. Epub 2021 Jun 7.
- Results publication: PubMed 30111322Knight GM, Dyakova E, Mookerjee S, Davies F, Brannigan ET, Otter JA, Holmes AH. Fast and expensive (PCR) or cheap and slow (culture)? A mathematical modelling study to explore screening for carbapenem resistance in UK hospitals. BMC Med. 2018 Aug 16;16(1):141. doi: 10.1186/s12916-018-1117-4.
- Results publication: PubMed 38479092A C, N C, A S, A P, E Y, F G, M C. Validation of a rapid molecular detection test for gram-negative multidrug-resistant bacteria in rectal swabs upon admission of patients to the intensive care unit. Diagn Microbiol Infect Dis. 2024 Jun;109(2):116250. doi: 10.1016/j.diagmicrobio.2024.116250. Epub 2024 Mar 8.
- Results publication: PubMed 39679488Fasciana T, Antonelli A, Bianco G, Lombardo D, Codda G, Roscetto E, Perez M, Lipari D, Arrigo I, Galia E, Tricoli MR, Calvo M, Niccolai C, Morecchiato F, Errico G, Stefani S, Cavallo R, Marchese A, Catania MR, Ambretti S, Rossolini GM, Pantosti A, Palamara AT, Sabbatucci M, Serra N, Giammanco A. [The CCM Project "Phenotypic and molecular screening methodologies for the detection of coloniza-tions due to carbapenem-resistant Enterobacterales (CRE)"]. Epidemiol Prev. 2024 Nov-Dec;48(6):470-475. doi: 10.19191/EP24.6.A806.137. Italian.
- Results publication: PubMed 39586760Lydeamore MJ, Wu D, Donker T, Gorrie C, Higgs CK, Easton M, Hennessy D, Geard N, Howden BP, Cooper BS, Wilson A, Peleg AY, Stewardson AJ. Changes in isolation guidelines for CPE patients results in only mild reduction in required hospital beds. Infect Dis Health. 2025 May;30(2):128-131. doi: 10.1016/j.idh.2024.10.004. Epub 2024 Nov 24.
- Results publication: PubMed 34146625Jimenez A, Fennie K, Munoz-Price LS, Ibrahimou B, Pekovic V, Abbo LM, Martinez O, Rosello G, Sposato K, Doi Y, Trepka MJ. Duration of carbapenemase-producing Enterobacteriales carriage among ICU patients in Miami, FL: A retrospective cohort study. Am J Infect Control. 2021 Oct;49(10):1281-1286. doi: 10.1016/j.ajic.2021.06.006. Epub 2021 Jun 17.
- Results publication: PubMed 23449280Zimmerman FS, Assous MV, Bdolah-Abram T, Lachish T, Yinnon AM, Wiener-Well Y. Duration of carriage of carbapenem-resistant Enterobacteriaceae following hospital discharge. Am J Infect Control. 2013 Mar;41(3):190-4. doi: 10.1016/j.ajic.2012.09.020.
- Results publication: PubMed 39069006van Veen A, de Goeij I, Damen M, Huijskens EGW, Paltansing S, van Rijn M, Bentvelsen RG, Veenemans J, van der Linden M, Vos MC, Severin JA; Infection Prevention and Antimicrobial Resistance Care Network South-western Netherlands. Regional variation in the interpretation of contact precautions for multi-drug-resistant Gram-negative bacteria: a cross-sectional survey. J Hosp Infect. 2024 Oct;152:1-12. doi: 10.1016/j.jhin.2024.06.020. Epub 2024 Jul 26.
- Surveillance of antimicrobial resistance in Europe 2017. In: European Centre for Disease Prevention and ControlLink provided by the sponsor.
- Prevention I. Guidelines for the prevention and control of carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in health care facilities. World Health Organization; 1 Nov 2017Link provided by the sponsor.
- Nov. ALGORITMOS DE DETECCIÓN DE CARBAPENEMASAS 2024.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilio Felipe Huaier Arriazu, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Rapid PCR-based algorithm for CPE detection in people with Carbapenemase-Producing Enterobacterales (CPE) Colonization, run by Hospital Italiano de Buenos Aires.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilio Felipe Huaier Arriazu, MD (+549 011 49590200 ext. 8165 / 9542, emilio.huaier@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07397416, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.