About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces
Spearman correlation coefficient between the quantitative bacterial load of carbapenemase-producing Enterobacterales in rectal surveillance swabs, measured by culture on CHROMagar™ KPC selective medium and expressed as colony-forming units per swab (CFU/swab), and the number of CPE-positive high-touch surfaces out of 5 sampled (bed linen, bedside table, and infusion pump), assessed by quantitative culture on CHROMagar™ KPC contact plates.
Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces
Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales, and the number of CPE-positive high-touch surfaces out of 5 sampled (bed linen, bedside table, and infusion pump), assessed by quantitative culture on CHROMagar™ KPC contact plates.
Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces
Spearman correlation coefficient between the quantitative bacterial load of carbapenemase-producing Enterobacterales in rectal surveillance swabs, measured by culture on CHROMagar™ KPC selective medium and expressed as colony-forming units per swab (CFU/swab), and the total colony-forming units (CFU) recovered across five high-touch surfaces (bed linen, bedside table, and infusion pump) surrounding colonized patients, assessed by quantitative culture on CHROMagar™ KPC contact plates.
Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces
Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales, and the total colony-forming units (CFU) recovered across five high-touch surfaces (bed linen, bedside table, and infusion pump) surrounding colonized patients, assessed by quantitative culture on CHROMagar™ KPC contact plates.
Sponsors and contacts
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Hospital Italiano de Buenos Aires
Lead sponsor
National Council of Scientific and Technical Research, Argentina
Collaborator
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