NCT07481539

Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment

Evaluation of the Pharmacokinetics of Subcutaneous Administration of Piperacillin/Tazobactam: an Open-Label, Multicentric, Non-inferiority Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Azienda Sanitaria Universitaria Friuli Centrale · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bacteria Infection
• Piperacillin, Tazobactam Drug Combination

Interventions

Type	Name	Description
DEVICE	Piperacillin, Tazobactam Drug Combination	Participants randomized to the experimental arm will receive piperacillin/tazobactam by continuous subcutaneous infusion from D1 to D7 (end at D8), at a total daily dose of 18 g/day, administered via syringe pump. The study drug will be prepared every 12 hours as 9 g in 40 mL of 0.9% sodium chloride in a polypropylene syringe and infused through a small subcutaneous cannula (22-24G). Preferred insertion sites are the abdomen, followed by the thigh or arm. Cannula insertion and management will follow aseptic no-touch technique, with site change only if clinically indicated based on patient comfort or local site findings. Renal dose adjustments will be applied according to protocol.
DRUG	Piperacillin, Tazobactam Drug Combination	Participants randomized to the control arm will receive piperacillin/tazobactam by continuous intravenous infusion from D1 to D7 (end at D8), at a total daily dose of 18 g/day. The study drug will be prepared every 24 hours as 18 g in 500 mL of 0.9% sodium chloride and administered through an electronic infusion pump using a dedicated intravenous line. Intravenous access may be peripheral or central, according to clinical practice and local requirements. Infusion line management and site care will follow local aseptic procedures and institutional standards. Renal dose adjustments will be applied according to protocol.

Timeline

• Start date: 2026-03-24
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Italy