Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italia/UD, Italy, 33100
Actively Recruiting
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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