NCT06651047 PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
| NCT ID | NCT06651047 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bologna |
| Condition | Gram Negative Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-07-09 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06651047 clinical trial?
This trial is open to participants of all sexes, studying Gram Negative Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06651047 currently recruiting?
Yes, NCT06651047 is actively recruiting participants. Contact the research team at maddalena.giannella@unibo.it for enrollment information.
Where is the NCT06651047 trial being conducted?
This trial is being conducted at Bologna, Italy, Catania, Italy, Milan, Italy, Padova, Italy and 7 additional locations.
Who is sponsoring the NCT06651047 clinical trial?
NCT06651047 is sponsored by University of Bologna. The trial plans to enroll 120 participants.