PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Dec 1, 2024
Trial Information
Current as of July 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how effective a combination of two antibiotics, ceftazidime/avibactam (CAZ/AVI) and fosfomycin (FOS), is in treating serious infections caused by certain bacteria that are resistant to many common antibiotics. These bacteria belong to a group known as carbapenem-resistant Enterobacterales (CRE), which can be very difficult to treat. The study involves adult patients who have been receiving one of these treatments for at least two days and aims to understand how the two medications work together in fighting these infections.
To participate in this trial, individuals need to be at least 18 years old and must have a confirmed infection caused by CRE. They should be receiving treatment with either CAZ/AVI alone or in combination with FOS for a minimum of 48 hours. It's important to note that patients with mixed infections involving other types of bacteria might not be eligible for this study. Those who join the trial can expect to be monitored closely, and their responses to the treatments will help researchers learn more about how to effectively tackle these tough infections.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signature of the informed consent
- • Age ≥ 18 years
- • Adult patients treated for ≥ 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically documented CRE infection
- Exclusion Criteria:
- • Polymicrobial/mixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs
About Irccs Azienda Ospedaliero Universitaria Di Bologna
IRCCS Azienda Ospedaliero-Universitaria di Bologna is a prestigious research and healthcare institution in Italy, renowned for its commitment to advancing medical science and patient care through innovative clinical research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with scientific research, facilitating the translation of laboratory findings into effective treatment strategies. The institution fosters a multidisciplinary approach, collaborating with various experts to conduct high-quality clinical trials aimed at improving health outcomes across a wide range of medical fields. With a strong emphasis on ethical standards and patient welfare, IRCCS Azienda Ospedaliero-Universitaria di Bologna plays a vital role in shaping the future of medicine through rigorous scientific inquiry and patient-centered care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, , Italy
Seville, , Spain
Patients applied
Trial Officials
Maddalena Giannella, MD PhD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported