PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections

Recruiting now

Conditions studied: Gram Negative Infection, Antimicrobial Resistance (AMR)

In brief

A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination therapy with ceftazidime/avibactam associated with fosfomycin (FOS) or cefiderocol associated with fosfomycin.

Key facts

Study ID

NCT06651047

Run by

University of Bologna

People needed

120

Starts

2024-07-09

Expected to finish

2025-09-30

Last updated by the study team

2024-10-21

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with infection due to a difficult-to-treat Gram-negative bacteria treated with CAZ/AVI alone, CEF alone, CAZ/AVI plus FOS, or CEF plus FOS (any age)
• Signature of the informed consent (for pediatric patients: parents or guardians able to provide consent)

You may not qualify if…

• Premature newborns
• Polymicrobial/mixed infections with the exception of cases with multiple Gram-negative bacteria susceptible to study drugs
• Continuous renal replacement therapy (CRRT) applications
• Inclusion Criteria for Healthy Volunteer Subjects:
• Age ≥18 years
• Signature of the informed consent
• Exclusion Criteria for Healthy Volunteer Subjects:
• Any known clinically relevant health problems

Where it is running

• Irccs Aoubo — Bologna, Italy (enrolling)
• Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi — Catania, Italy
• ASST-FBF-Sacco — Milan, Italy
• Azienda Ospedale - Università Padova — Padova, Italy
• Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT) — Palermo, Italy
• Policlinico Umberto I — Rome, Italy
• Policlinico Universitario Campus Bio-Medico — Rome, Italy
• Ospedale Pediatrico Bambin Gesù — Rome, Italy
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy
• Azienda Ospedaliero Universitaria Senese — Siena, Italy
• Città della salute e della Scienza, Molinette — Turin, Italy

Full record on ClinicalTrials.gov

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