Actively Recruiting
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
Led by University of Bologna · Updated on 2024-10-21
120
Participants Needed
11
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 65;18 years for healthy volunteer subjects
- Signature of the informed consent for healthy volunteer subjects
You will not qualify if you...
- Premature newborns
- Polymicrobial/mixed infections except cases with multiple Gram-negative bacteria susceptible to study drugs
- Continuous renal replacement therapy (CRRT) applications
- Any known clinically relevant health problems for healthy volunteer subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Irccs Aoubo
Bologna, Italy, 40138
Actively Recruiting
2
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi
Catania, Italy, 95124
Not Yet Recruiting
3
ASST-FBF-Sacco
Milan, Italy, 20157
Not Yet Recruiting
4
Azienda Ospedale - Università Padova
Padova, Italy, 35128
Not Yet Recruiting
5
Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)
Palermo, Italy, 90127
Not Yet Recruiting
6
Policlinico Umberto I
Rome, Italy, 00100
Not Yet Recruiting
7
Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
Not Yet Recruiting
8
Ospedale Pediatrico Bambin Gesù
Rome, Italy, 00165
Not Yet Recruiting
9
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Not Yet Recruiting
10
Azienda Ospedaliero Universitaria Senese
Siena, Italy, 53100
Not Yet Recruiting
11
Città della salute e della Scienza, Molinette
Turin, Italy, 10126
Not Yet Recruiting
Research Team
M
Maddalena Giannella, MD PhD
CONTACT
N
Natascia Caroccia, PhD
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
1
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