RecruitingNCT06651047

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

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


Sponsor

University of Bologna

Enrollment

120 participants

Start Date

Jul 9, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria4

  • 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)
  • Age ≥18 years
  • Signature of the informed consent

Exclusion Criteria4

  • 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
  • \- Any known clinically relevant health problems

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Locations(11)

Irccs Aoubo

Bologna, Italy

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

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NCT06651047


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