Ceftazidime/Avibactam and Fosfomycin for CRE Infections

PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE

Recruiting Observational Study
Gram Negative Infections Antimicrobial Resistance (AMR)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
60 (estimated)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Other
Who this trial is looking for

This trial is looking for adult patients who have infections caused by certain resistant bacteria. Participants will receive either a combination of two medications or one of them alone for at least 48 hours.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old
  • I have signed the informed consent
  • I have a confirmed infection caused by carbapenem-resistant Enterobacterales
  • I have been treated for at least 48 hours with CAZ/AVI or CAZ/AVI plus FOS

You may not be able to join if

  • I have a mixed infection with other types of bacteria, unless they are also susceptible to the study drugs

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial

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).

Trial Locations
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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 Enterobacte…
Contacts

Maddalena Giannella, MD PhD

+390512143199

maddalena.giannella@unibo.it

CONTACT