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NOT YET RECRUITING
NCT07685132

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

Sponsor: Hospital Italiano de Buenos Aires

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-08-01

Completion Date

2027-01-15

Last Updated

2026-07-06

Healthy Volunteers

No

Locations (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina