Actively Recruiting
Nosocomial Infections in ECMO Patients
Led by Policlinico Hospital · Updated on 2024-07-10
200
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
P
Policlinico Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nosocomial Infections in ECMO Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Diagnosis of ARDS with acute onset within 7 days, bilateral lung opacities not explained by other causes, P/F ratio ≤ 300 mmHg, and positive airway pressure ≥ 5 cmH2O
- Currently undergoing ECMO treatment
- Receiving antibiotic treatment with ceftazidime/avibactam, meropenem/vaborbactam, ceftolozane/tazobactam, or cefiderocol (for the pharmacokinetic study subgroup)
You will not qualify if you...
- Pregnancy
- Expected survival less than 24 hours
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122
Actively Recruiting
2
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, Italy, 20100
Not Yet Recruiting
Research Team
G
Giacomo Grasselli, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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