No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
120 (estimated)
Sponsor
University of Bologna · Other
Who this trial is looking for
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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.
Trial Locations
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Facility
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Status
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 C…
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
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