Nosocomial Infections in ECMO Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Collection of blood and bronchoalveolar samples to study Pharmacokinetics of ceftazidime/avibactam, meropenem/varbobactam, ceftolozane/tazobactam, or cefiderocol: The antibiotic treatment with ceftazidime/avibactam, meropenem/vaborbactam, ceftolozane/tazobactam, or cefiderocol will follow the standard clinical practice. The concentration of ceftazidime/avibactam, meropenem/vaborbactam, ceftolozane/tazobactam, or cefiderocol will be measured at specific timepoints in plasma samples and bronchoalveolar lavage samples, and a PK analysis and modeling will be carried out .

Study summary

Nosocomial Infections (NI) are a common and dreadful complication for patients suffering from Acute Respiratory Distress Syndrome (ARDS) treated with Extracorporeal Membrane Oxygenation (ECMO). Unfortunately, no study has thoroughly evaluated NI in this fragile patient cohort. Newly developed antibiotics may help manage such infections, but their pharmacokinetics (PK) during ECMO has not been evaluated.

Objectives of this prospective observational multicenter pharmacological no-profit study are: 1) describe incidence, microbial etiology, and resistance patterns, and assess risk factors for NIs in a large prospective cohort of ARDS patients undergoing ECMO. 2) provide a PK analysis of ceftazidime/avibactam, meropenem/vaborbactam, ceftolozane/tazobactam, and cefiderocol in adult patients undergoing ECMO Incidence, microbial etiology, and antibiotic resistance patterns of confirmed NIs will be prospectively collected and analyzed. In the subgroup of patients treated with ceftazidime/avibactam, meropenem/vaborbactam, ceftolozane/tazobactam, or cefiderocol as per clinical practice, blood and bronchoalveolar concentration of the antibiotic will be measured, and PK modeling carried out.

Eligibility

Primary outcome measure(s)

• Incidence of NIs in a large prospective cohort of patients undergoing ECMO. — January 2023-December 2025
  Only microbiologically-confirmed infections will be considered. Accordingly, the composite outcome (i.e., infected patient) will be composed of the following NIs: ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (UTI), bloodstream infection (BSI), and catheter-related bloodstream infection (CRBSI). Incidence of pulmonary aspergillosis and clostridium difficile colitis will be collected but not included in the composite outcome (i.e., infected patient). To carry out this aim, a supervisor for each participating center will be in charge of patients' follow-up. For each center, a critical care specialist and an infectious disease specialist will review the available clinical and laboratory data. Incidence will be expressed as: 1) percentage of patients who will develop a NI/total of patients; 2) rate of incidence: number of infection/total time at risk of NIs.
• Microbial etiology of NIs in a large prospective cohort of patients undergoing ECMO. — January 2023-December 2025
  Only microbiologically-confirmed infections will be considered. Accordingly, the composite outcome (i.e., infected patient) will be composed of the following NIs: ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (UTI), bloodstream infection (BSI), and catheter-related bloodstream infection (CRBSI). Incidence of pulmonary aspergillosis and clostridium difficile colitis will be collected but not included in the composite outcome (i.e., infected patient). To carry out this aim, a supervisor for each participating center will be in charge of patients' follow-up. For each center, a critical care specialist and an infectious disease specialist will review the available clinical and laboratory data. Different microbial etiology will be described according to simple descriptive statistics methods.
• Resistance patterns of NIs in a large prospective cohort of patients undergoing ECMO. — January 2023-December 2025
  Only microbiologically-confirmed infections will be considered. Accordingly, the composite outcome (i.e., infected patient) will be composed of the following NIs: ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (UTI), bloodstream infection (BSI), and catheter-related bloodstream infection (CRBSI). Incidence of pulmonary aspergillosis and clostridium difficile colitis will be collected but not included in the composite outcome (i.e., infected patient). To carry out this aim, a supervisor for each participating center will be in charge of patients' follow-up. For each center, a critical care specialist and an infectious disease specialist will review the available clinical and laboratory data. Resistance patterns of NIs' microbes will be described according to simple descriptive statistics methods.
• Risk factors of NIs in a large prospective cohort of patients undergoing ECMO. — January 2023-December 2025
  Only microbiologically-confirmed infections will be considered. Accordingly, the composite outcome (i.e., infected patient) will be composed of the following NIs: ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (UTI), bloodstream infection (BSI), and catheter-related bloodstream infection (CRBSI). Incidence of pulmonary aspergillosis and clostridium difficile colitis will be collected but not included in the composite outcome (i.e., infected patient). To carry out this aim, a supervisor for each participating center will be in charge of patients' follow-up. For each center, a critical care specialist and an infectious disease specialist will review the available clinical and laboratory data. Multivariate analysis will be conducted to evaluate risk factors of NIs. For each risk factor identified Odds Ratio with 95% Confidence Interval will be reported.

Trial sites (2)

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