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

ConditionsGram Negative InfectionAntimicrobial Resistance (AMR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Bologna

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Age ≥18 years

Trial population

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), hospitalized during the study period in the participating centers, will be screened for inclusion

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Patients with difficult-to-treat gram-negative infection treated with CAZ/AVI or CEF, ± FOS

Trial outcomes

Primary outcomes

1

PK/PD efficacy targets for study drugs

Primary endpoint will be the proportion of patients achieving the PK/PD efficacy target. Since these drugs are widely used in clinical practice, safety is not evaluated in this study

Time frame
From enrollment (treatment onset) to the end of treatment (up to 7 days)

Secondary outcomes

1

Difference in SOFA score

Difference in SOFA score (pSOFA for pediatric patients) between day 0 (day of index positive cultures) and day 7

Time frame
From day 0 (day of index positive culture) and day 7
2

Difference in C-Reactive Protein (CRP), Procalcitonin (PCT) and Interleukin-6 (IL-6)

Difference in C-Reactive Protein (CRP), Procalcitonin (PCT) and Interleukin-6 (IL-6) between day 0 and day 7

Time frame
From day 0 (day of index positive culture) and day 7
3

Identification of new protein-based biomarkers

* Difference in protein-based biomarkers at day 0 between study patients and a group of healthy subjects * Difference in protein-based biomarkers in study patients between different timepoints (from treatment onset to the end of treatment)

Time frame
From enrollment to the end of treatment (up to 7 days)
4

Microbiological eradication

Microbiological eradication defined as bacteremia clearance or negativization of index diagnostic samples within 7 days from index BC

Time frame
From day 0 (day of index positive culture) and day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bologna

Lead sponsor

Source ClinicalTrials.gov
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