PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Polymicrobial/mixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs
Trial population
Adult patients with infection due to a difficult-to-treat Gram-negative bacteria, treated with CAZ/AVI alone or CAZ/AVI plus FOS, 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
60 Participants
are grouped into 1 trial groupGroup A: Patients with Carbapenem-resistant Enterobacterales (CRE) infection treated with CAZ/AVI ± FOS
Trial outcomes
Primary outcomes
1
PK/PD efficacy targets for study drugs
The primary endpoint will be the attainment of the pre-defined PK/PD target of efficacy at 48 and 72 hours after starting treatment for Carbapenem-resistant Enterobacterales (CRE) infection
Time frame
From enrollment (treatment onset) to 48 and 72 hours after starting treatmentSecondary outcomes
1
Difference in SOFA score
Difference in SOFA score between day 0 (day of treatment onset) and day 7
Time frame
From day 0 (day of index positive culture) and day 72
Trend of C-Reactive Protein (CRP) and Procalcitonin (PCT)
Trend of C-Reactive Protein (CRP) and Procalcitonin (PCT) from day 0 to day 7 after treatment onset
Time frame
From day 0 (day of index positive culture) and day 73
Microbiological eradication
Microbiological eradication defined as bacteraemia clearance or negativization of index diagnostic sample within 7 days from treatment onset
Time frame
From day 0 (day of index positive culture) and day 74
Relapse and/or reinfection
Relapse (new infection with the same pathogen emerging after treatment) and/or reinfection (new infection with a different pathogen emerging after treatment) rates at day 90
Time frame
From enrollment to the end of the follow-up at three monthsSponsors and contacts
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Source ClinicalTrials.gov