Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07481539

Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment

Led by Azienda Sanitaria Universitaria Friuli Centrale · Updated on 2026-03-19

240

Participants Needed

1

Research Sites

57 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed free, written, informed consent
  • At least 18 years old at inclusion
  • Male or female participants
  • Clinical indication for piperacillin/tazobactam 18g/day continuous infusion for severe pneumonia, neutropenic fever suspected bacterial infection, or other severe bacterial infections where this dosing is appropriate
  • Evidence of postmenopausal status or negative pregnancy tests for women of childbearing potential who are sexually active with non-sterilized male partners
  • Admitted to an authorized study ward
Not Eligible

You will not qualify if you...

  • Known allergy to penicillins, cephalosporins, beta-lactamase inhibitors, or any component of the study drug
  • Pregnant or breastfeeding women or planning pregnancy during the study or at end-of-treatment
  • Women of childbearing potential unwilling or unable to use highly effective contraception throughout the study and at end-of-treatment
  • No indication for piperacillin/tazobactam treatment
  • Known resistance to piperacillin/tazobactam
  • Any disease or condition that contraindicates study drug use or affects result interpretation or increases treatment risk
  • Participation in another investigational drug trial within 30 days prior to screening or within 5 half-lives of that drug

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italia/UD, Italy, 33100

Actively Recruiting

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Research Team

C

Carlo Tascini, Full Professor

CONTACT

C

Chiara Moreal, MSn RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment | DecenTrialz