Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT06651047
Recruiting Observational

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

NCT06651047 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Bologna
Phase
Observational
Started
2024-07-09
Last updated
2024-10-21

Condition(s) studied

Gram Negative InfectionAntimicrobial Resistance (AMR)

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • PK/PD efficacy targets for study drugs — From enrollment (treatment onset) to the end of treatment (up to 7 days)
    Primary endpoint will be the proportion of patients achieving the PK/PD efficacy target. Since these drugs are widely used in clinical practice, safety is not evaluated in this study

Trial sites (11)

FacilityCityRegionStatus
Irccs Aoubo Bologna Italy Recruiting
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi Catania Italy Not Yet Recruiting
ASST-FBF-Sacco Milan Italy Not Yet Recruiting
Azienda Ospedale - Università Padova Padova Italy Not Yet Recruiting
Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT) Palermo Italy Not Yet Recruiting
Policlinico Umberto I Rome Italy Not Yet Recruiting
Policlinico Universitario Campus Bio-Medico Rome Italy Not Yet Recruiting
Ospedale Pediatrico Bambin Gesù Rome Italy Not Yet Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Not Yet Recruiting
Azienda Ospedaliero Universitaria Senese Siena Italy Not Yet Recruiting
Città della salute e della Scienza, Molinette Turin Italy Not Yet Recruiting

More University of Bologna trials in Italy

Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy Active, not recruiting
Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox Starting soon
Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS Recruiting
A Standard Carbon Dioxide Flushing Protocol to Reduce Air Embolization During Thoracic Endovascular Aortic Repair Recruiting
CardioVascular Disease Progression and Prognosis in COVID-19 Recruiting

Other trials for the same condition

PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06651047 on ClinicalTrials.gov ↗ ← All trials in Italy