Actively Recruiting
Pharmacokinetic/Pharmacodynamic 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the pharmacokinetics and pharmacodynamics (PK/PD) of antibiotics ceftazidime/avibactam (CAZ/AVI), cefiderocol (CEF), and fosfomycin (FOS) in patients with difficult-to-treat Gram-negative bacterial infections. The study aims to optimize antibiotic dosing using Therapeutic Drug Monitoring (TDM) to improve outcomes, especially in high-risk patients such as those with pneumonia or renal disease. It also focuses on pediatric use, where CAZ/AVI is approved for children older than 3 months but cefiderocol is not. Patients of any age with infections caused by difficult-to-treat Gram-negative bacteria are observed while receiving treatment with CAZ/AVI alone, CEF alone, or in combination with FOS. The study does not assign treatments but monitors patients treated with these regimens in clinical practice. The primary goal is to evaluate how well these treatments achieve predefined PK/PD efficacy targets. During the study, researchers assess clinical biomarkers, microbiological eradication, and protein biomarkers from the start of treatment up to 7 days, with follow-up monitoring for relapse, reinfection, and mortality over three months. The study uses data collected during routine care, including biomarker trends and microbiological tests, to understand treatment effects and optimize dosing strategies.
CONDITIONS
Brief 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 of any age with infection due to difficult-to-treat Gram-negative bacteria treated with CAZ/AVI alone, CEF alone, CAZ/AVI plus FOS, or CEF plus FOS
- Signed informed consent (for children, parents or guardians must provide consent)
- Healthy volunteers aged 18 years or older with signed informed consent
You will not qualify if you...
- Premature newborns
- Polymicrobial or mixed infections except cases with multiple Gram-negative bacteria susceptible to study drugs
- Patients undergoing continuous renal replacement therapy (CRRT)
- Healthy volunteers with any known clinically relevant health problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive antibiotic therapy with ceftazidime/avibactam or cefiderocol, with or without fosfomycin, to treat difficult-to-treat Gram-negative infections while undergoing pharmacokinetic/pharmacodynamic monitoring.
Visits occur from treatment onset to end of treatment
Duration - Up to 3 months
Participants are monitored for relapse, reinfection, and survival outcomes after completing treatment.
Visits during follow-up period as scheduled
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
N
Natascia Caroccia, PhD
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here