Investigating infections in patients on ECMO for severe respiratory failure
Nosocomial Infections in Patients Treated With Extracorporeal Membrane Oxygenation
This study looks at infections in patients with severe lung failure on ECMO to see what causes them and how to better treat them with antibiotics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Policlinico Hospital Academic / other |
| Locations | 2 sites (Milan, MI and 1 other locations) |
| Trial ID | NCT05566665 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence, microbial causes, and resistance patterns of nosocomial infections (NIs) in patients with Acute Respiratory Distress Syndrome (ARDS) who are undergoing Extracorporeal Membrane Oxygenation (ECMO). It will also analyze the pharmacokinetics of specific antibiotics in this patient population. By collecting and analyzing data from a large cohort, the study seeks to improve understanding of NIs and optimize antibiotic treatment strategies. The findings could lead to better management of infections in critically ill patients on ECMO.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with ARDS who are currently receiving ECMO.
Not a fit: Patients who are pregnant or have an expected survival of less than 24 hours will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the treatment of nosocomial infections in ECMO patients, potentially improving survival rates and outcomes.
How similar studies have performed: While few studies have assessed nosocomial infections in ECMO patients, this prospective approach is novel and aims to fill a significant gap in existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, MI and 1 other locations
- Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico — Milan, Mi, Italy (Recruiting)
- Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico — Milan, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Vittorio Scaravilli, MD — University of Milan
- Study coordinator: Giacomo Grasselli, MD
- Email: giacomo.grasselli@unimi.it
- Phone: +390255033285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.