Nosocomial Infections in ECMO Patients
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 manag
| Condition(s) | Acute Respiratory Distress Syndrome, Nosocomial Infection, Extracorporeal Membrane Oxygenation Complication |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 und |
| Who can participate | Inclusion Criteria: * Age \> 18 years * Diagnosis of ARDS (i.e., acute onset ( \< 7 days) from the known clinical insult of respiratory failure, with bilateral opacities - not explained by effusions, lung and lobar collapse, or nodules -, not fully explained by cardiac failure/fluid overload; with P/F ratio \<= 300 mmHg and continuous positive airway pressure \>= 5 cmH2O) * Ongoing ECMO Adjunctive Inclusion Criterium for the sole Secondary Objective: \- Antibiotic treatment with ceftazidime/avibactam, meropenem/vaborbactam, ceftolozane/tazobactam, or cefiderocol. Exclusion Criteria: * Pregnancy * Expected survival \< 24 hours. |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Lead sponsor | Policlinico Hospital |
| Locations | Milan, MI, Italy; Milan, Italy |
| Start date | 2023-01-01 |
| NCT ID | NCT05566665 |
| Official listing | https://clinicaltrials.gov/study/NCT05566665 |