drugset / Trial / NCT07481539

Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment

NCT07481539

Phase 2 Recruiting 240 enrolled Azienda Sanitaria Universitaria Friuli Centrale
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn whether subcutaneous piperacillin/tazobactam can provide drug exposure similar to standard intravenous piperacillin/tazobactam in adults who need treatment for an infection. It will also assess safety and clinical outcomes. The main questions it aims to answer are: * Does subcutaneous piperacillin/tazobactam achieve pharmacokinetic exposure comparable to intravenous treatment? * Is subcutaneous piperacillin/tazobactam safe and feasible in this population? Researchers will compare subcutaneous continuous infusion with intravenous continuous infusion to see whether the subcutaneous route is not clinically worse than the standard intravenous route. Participants will: * Receive piperacillin/tazobactam by subcutaneous or intravenous continuous infusion after randomization * Have blood samples collected for pharmacokinetic assessments * Undergo safety, clinical, and end-of-treatment assessments during the study period

Timeline

Start
2026-03-24
Primary completion
2027-04-30
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Piperacillin Small molecule Subcutaneous
Subject Tazobactam Small molecule Subcutaneous