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

Launched by UNIVERSITY OF BOLOGNA · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying different treatments for patients with challenging Gram-negative infections, which are types of bacteria that can be hard to treat, especially due to resistance to antibiotics. The trial is looking at how effective two specific antibiotics—ceftazidime/avibactam (CAZ/AVI) and cefiderocol (CEF)—work alone or in combination with another antibiotic called fosfomycin (FOS). The goal is to find the best way to treat these difficult infections and improve patient outcomes.

To be eligible for this trial, patients of any age must have a Gram-negative infection that is tough to treat and be receiving one of the study antibiotics, either alone or with fosfomycin. Parents or guardians can give consent for younger patients. However, premature newborns and those with certain complex infections or specific health issues may not be able to participate. For healthy volunteers aged 18 and older, signing a consent form is required, and they should not have any significant health problems. Participants will be monitored closely throughout the trial, helping to gather important information about these treatments.

Gender

ALL

Eligibility 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