NCT06717594 PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
| NCT ID | NCT06717594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Gram Negative Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-09-30 |
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 60 participants in total. It began in 2023-12-01 with a primary completion date of 2026-09-30.
⚠ 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 international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and/or OXA-48).
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
Contact & Investigator
Maddalena Giannella, MD PhD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06717594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gram Negative Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06717594 currently recruiting?
Yes, NCT06717594 is actively recruiting participants. Contact the research team at maddalena.giannella@unibo.it for enrollment information.
Where is the NCT06717594 trial being conducted?
This trial is being conducted at Bologna, Italy, Seville, Spain.
Who is sponsoring the NCT06717594 clinical trial?
NCT06717594 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Maddalena Giannella, MD PhD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 60 participants.