Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Sanitaria Universitaria Friuli Centrale
About this trial
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
Eligibility criteria
Qualifiers
Free, written and informed consent signed by the participant;
At least 18 years old on the day of inclusion;
Male and female participants;
Clinical indication for treatment with piperacillin/tazobactam 18g/die in continuous infusion, including severe pneumonia, neutropenic fever suspected to be caused by bacterial infection or other severe bacterial infections for which, based on investigator's judgment, this dosage regimen is appropriate;
Disqualifiers
Known hypersensitivity to penicillins, cephalosporins, other β-lactamase inhibitors, or any component of the formulation;
Pregnant or breastfeeding women, and women intending to become pregnant during the study or within the End-of-Treatment visit;
Women of childbearing potential (WOCBP) unwilling or unable to use at least one highly effective method of contraception, as defined in Section 7.4, throughout study participation and for at least at the End-of-Treatment visit;
No indication for treatment with TZP;
Trial design
Treatments tested in this trial
- Piperacillin, Tazobactam Drug Combination
- Piperacillin, Tazobactam Drug Combination
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov