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

Recruitingn/aAges any - anyAllUniversity of Bologna
NCT06651047 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

11 sites
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

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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