Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units

NCT07685132 | Not Yet Recruiting DMC

• 1 other identifier: 7703
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs). Some colonized individuals may carry a particularly high bacterial burden and contribute disproportionately to environmental contamination and transmission to other patients. Identifying these high-risk individuals could improve infection prevention and control strategies. This prospective observational study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. Patients identified as colonized with CPE through routine surveillance will undergo quantitative culture and real-time polymerase chain reaction (PCR) testing of rectal swabs to measure bacterial load. Environmental samples will also be collected from high-touch surfaces surrounding colonized patients. In selected cases, molecular typing methods will be used to evaluate genetic relatedness between patient and environmental isolates and to investigate possible transmission events. The primary objective is to determine the correlation between bacterial load measured by culture and the PCR cycle threshold (Ct) value. Secondary objectives include evaluating the association between bacterial load and environmental contamination, and assessing whether patients with higher bacterial loads are more likely to contribute to transmission within the ICU. Results may help identify patients with increased dissemination potential and support targeted infection prevention interventions.

Conditions

Healthcare-Associated Infections (HAIs); Antimicrobial Resistance (AMR); Carbapenem-Resistant Enterobacteriaceae Colonization

Keywords

Carbapenemase-Producing Enterobacterales; CPE; Colonization; Super-Spreader; Cycle Threshold; Ct Value; Real-Time PCR; Environmental Contamination; Nosocomial Transmission; Infection Prevention and Control; Intensive Care Unit; Multidrug Resistance; Antimicrobial Resistance

Outcome Measures

Primary Outcomes (1)

• Correlation Between PCR Cycle Threshold (Ct) Value and Quantitative Bacterial Load (CFU/swab) in Rectal Surveillance Swabs

  Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes and the quantitative bacterial load measured by culture on CHROMagar™ KPC selective medium, expressed as colony-forming units per swab (CFU/swab), from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales.

  At baseline (time of positive rectal surveillance swab)

Secondary Outcomes (6)

• Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces

  Within 24 hours of rectal swab collection

• Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces

  Within 24 hours of rectal swab collection

• Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces

  Within 24 hours of rectal swab collection

• Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces

  Within 24 hours of rectal swab collection

• Number of Index Patients with Transmission of at Least One Genetically Related CPE Strain to a Co-Hospitalized Patient

  Up to 6 months

Study Arms (1)

CPE-Colonized ICU Patients

Patients admitted to the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales (CPE). Participants will undergo quantitative culture and real-time PCR testing of rectal swabs as part of routine surveillance. Environmental samples will be collected from high-touch surfaces surrounding colonized patients to evaluate environmental contamination and transmission dynamics.

Eligibility Criteria

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

Study Population

Adult patients hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period, with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales detected through the institutional infection control surveillance program.

You may qualify if:

• Age 18 years or older.
• Hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period.
• Positive surveillance rectal swab for carbapenemase-producing Enterobacterales.

You may not qualify if:

• Patients colonized or infected with carbapenemase-producing Enterobacterales who remained in the same room for less than 48 hours.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• National Council of Scientific and Technical Research, Argentina: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1199, Argentina

Location

Related Publications (5)

• Tenover FC, Arbeit RD, Goering RV, Mickelsen PA, Murray BE, Persing DH, Swaminathan B. Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing. J Clin Microbiol. 1995 Sep;33(9):2233-9. doi: 10.1128/jcm.33.9.2233-2239.1995. No abstract available.

  PMID: 7494007 BACKGROUND

• Gomez SA, Pasteran FG, Faccone D, Tijet N, Rapoport M, Lucero C, Lastovetska O, Albornoz E, Galas M; KPC Group; Melano RG, Corso A, Petroni A. Clonal dissemination of Klebsiella pneumoniae ST258 harbouring KPC-2 in Argentina. Clin Microbiol Infect. 2011 Oct;17(10):1520-4. doi: 10.1111/j.1469-0691.2011.03600.x. Epub 2011 Aug 18.

  PMID: 21851480 BACKGROUND

• Wei M, Chen X, Liu J, Li T, Wang P, Wang S, Wang J, Gu L. Development and Validation of a Novel Multiplex Real-Time PCR Assay for Rapid Detection of Carbapenemase Genes in Carbapenem-Resistant Enterobacterales Isolates and Clinical Samples. Infect Drug Resist. 2024 Aug 9;17:3451-3462. doi: 10.2147/IDR.S475630. eCollection 2024.

  PMID: 39139626 BACKGROUND

• Lerner A, Romano J, Chmelnitsky I, Navon-Venezia S, Edgar R, Carmeli Y. Rectal swabs are suitable for quantifying the carriage load of KPC-producing carbapenem-resistant Enterobacteriaceae. Antimicrob Agents Chemother. 2013 Mar;57(3):1474-9. doi: 10.1128/AAC.01275-12. Epub 2013 Jan 7.

  PMID: 23295937 BACKGROUND

• Lerner A, Adler A, Abu-Hanna J, Cohen Percia S, Kazma Matalon M, Carmeli Y. Spread of KPC-producing carbapenem-resistant Enterobacteriaceae: the importance of super-spreaders and rectal KPC concentration. Clin Microbiol Infect. 2015 May;21(5):470.e1-7. doi: 10.1016/j.cmi.2014.12.015. Epub 2014 Dec 26.

  PMID: 25684452 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Rectal surveillance swabs and environmental samples collected as part of routine infection control surveillance. Samples will undergo quantitative culture, real-time PCR for carbapenemase genes, and molecular characterization including genomic sequencing or PFGE when indicated.

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Ines Staneloni, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Ines Staneloni, MD

CONTACT

+549 011 49590200; maria.staneloni@hospitalitaliano.org.ar

Emilio Felipe Huaier Arriazu, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal may access de-identified participant data for scientific purposes. Requests will be reviewed by the principal investigator and the institutional ethics committee. Data sharing agreements may be required before data release.

Locations

AR (1)