| NCT ID | NCT05566665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Policlinico Hospital |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Vittorio Scaravilli, MD
PRINCIPAL INVESTIGATOR
University of Milan
Frequently Asked Questions
Who can join the NCT05566665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05566665 currently recruiting?
Yes, NCT05566665 is actively recruiting participants. Contact the research team at giacomo.grasselli@unimi.it for enrollment information.
Where is the NCT05566665 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy.
Who is sponsoring the NCT05566665 clinical trial?
NCT05566665 is sponsored by Policlinico Hospital. The principal investigator is Vittorio Scaravilli, MD at University of Milan. The trial plans to enroll 200 participants.