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

NCT07397416 | Not Yet Recruiting

• 1 other identifier: CEPI No. 7443 PRIISA 15728
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carbapenemase-Producing Enterobacterales (CPE) Colonization

Keywords

Healthcare-Associated Infections; Antimicrobial Resistance; Enterobacteriaceae Infections; Nosocomial Colonization; Infection Control

Outcome Measures

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

  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)

  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)

  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)

  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.

Study Arms (2)

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.

Diagnostic Test: Rapid PCR-based algorithm for CPE detection

Interventions

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.

Also known as: Rapid molecular diagnostic algorithm for CPE; BD MAX CPE PCR workflow

Post-intervention period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Related Publications (10)

• 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.

  PMID: 27593176 RESULT

• Orena 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.

  PMID: 39596746 RESULT

• Lim 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.

  PMID: 34111583 RESULT

• Knight 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.

  PMID: 30111322 RESULT

• A 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.

  PMID: 38479092 RESULT

• Fasciana 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.

  PMID: 39679488 RESULT

• Lydeamore 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.

  PMID: 39586760 RESULT

• Jimenez 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.

  PMID: 34146625 RESULT

• Zimmerman 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.

  PMID: 23449280 RESULT

• van 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.

  PMID: 39069006 RESULT

Related Links

• Surveillance of antimicrobial resistance in Europe 2017. In: European Centre for Disease Prevention and Control
• 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 2017
• Nov. ALGORITMOS DE DETECCIÓN DE CARBAPENEMASAS 2024.

MeSH Terms

Conditions

Cross Infection; Enterobacteriaceae Infections

Interventions

Cytopathogenic Effect, Viral

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Virus Physiological Phenomena; Microbiological Phenomena

Central Study Contacts

Emilio Felipe Huaier Arriazu, MD

CONTACT

+549 011 49590200; emilio.huaier@hospitalitaliano.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emilio Felipe Huaier Arriazu, MD. Principal Investigator, Infection Control Committee

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share