Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT05566665

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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