Analyzing antibiotic treatments for tough 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
This study is testing how well two antibiotics work for people with hard-to-treat Gram-negative infections to see if adjusting their doses can help them get better, especially in kids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | University of Bologna Academic / other |
| Locations | 11 sites (Bologna and 10 other locations) |
| Trial ID | NCT06651047 on ClinicalTrials.gov |
What this trial studies
This multicenter, national, prospective observational study focuses on patients with difficult-to-treat Gram-negative infections, specifically those caused by Carbapenem-resistant Enterobacterales. It evaluates the pharmacokinetics and pharmacodynamics of ceftazidime/avibactam or cefiderocol, both as monotherapy and in combination with fosfomycin. The study aims to optimize antibiotic dosing regimens through Therapeutic Drug Monitoring to improve clinical outcomes. Additionally, it seeks to gather more data on pediatric populations where these treatments are currently off-label.
Who should consider this trial
Good fit: Ideal candidates include patients of any age with infections caused by difficult-to-treat Gram-negative bacteria receiving specific antibiotic therapies.
Not a fit: Patients who are premature newborns or those undergoing continuous renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from difficult-to-treat Gram-negative infections.
How similar studies have performed: While there have been studies on antibiotic treatments for Gram-negative infections, this approach focusing on PK/PD optimization and Therapeutic Drug Monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna and 10 other locations
- 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)
Study contacts
- Study coordinator: Maddalena Giannella, MD PhD
- Email: maddalena.giannella@unibo.it
- Phone: +39 0512143199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.