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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Piperacillin, Tazobactam Drug Combination
DeviceParticipants 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.
Piperacillin, Tazobactam Drug Combination
DrugParticipants 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: SC ARMExperimental treatment 2 interventions
Group B: IV ARMActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
PK profile
Area under the plasma concentration-time curve (AUC) of piperacillin/tazobactam measured from plasma antibiotic concentrations collected for pharmacokinetic assessment at steady state.
Time frame
Day 3Secondary outcomes
1
Achieving target concentrations
Proportion of participants achieving the prespecified target piperacillin plasma concentration of at least 40 mg/L based on therapeutic drug monitoring and pharmacokinetic/pharmacodynamic criteria.
Time frame
Days 0, 1, 3, and 62
Clinical cure at end of treatment
Clinical cure rate at the end of treatment, defined as partial or complete resolution of baseline clinical signs and symptoms of infection without need for additional antibiotic therapy for the index infection.
Time frame
Day 83
Incidence of local and systemic adverse events
Incidence of local adverse events related to the administration route (including edema, pain, erythema, and necrosis) and systemic adverse events recorded during treatment.
Time frame
Up to Day 94
Health-related quality of life assessed by EQ-5D-5L
Health-related quality of life assessed with the EuroQol 5 Dimensions 5 Levels questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system includes 5 dimensions scored on 5 levels from 1 to 5; lower levels indicate better health status. Participants also complete the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where higher scores indicate better perceived health.
Time frame
Days 0, 3, and 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov