Infectious disease
Conditions
Brief summary
The area under the plasma concentration-time curve (AUC) of TZP, demonstrating that TZP administration is non-inferior to IV administration. PK profile will be evaluated through the plasma antibiotic concentrations, obtained by sample collection.
Detailed description
-Therapeutic drug monitoring of piperacillin to ensure target concentrations non-inferior than or equal to 40 mg/L between groups, aligning with established PK/PD clinical breakpoints established; - Clinical cure rate at the end of the treatment period, defined as the partial or complete resolution of clinical signs and symptoms of infection without the need for additional antibiotic therapy; -Microbiologic success rate at EOT; - Incidence of AEs: occurrences of AEs up to 1 day after the end
Interventions
DRUGPiperacillina e Tazobactam Ibigen 4 g/0
DRUG5 g polvere per soluzione per infusione
Sponsors
Azienda Sanitaria Universitaria Friuli Centrale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the plasma concentration-time curve (AUC) of TZP, demonstrating that TZP administration is non-inferior to IV administration. PK profile will be evaluated through the plasma antibiotic concentrations, obtained by sample collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Therapeutic drug monitoring of piperacillin to ensure target concentrations non-inferior than or equal to 40 mg/L between groups, aligning with established PK/PD clinical breakpoints established; - Clinical cure rate at the end of the treatment period, defined as the partial or complete resolution of clinical signs and symptoms of infection without the need for additional antibiotic therapy; -Microbiologic success rate at EOT; - Incidence of AEs: occurrences of AEs up to 1 day after the end | — |
Countries
Italy
Outcome results
None listed