Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment

NCT07481539 | Recruiting Phase 2

• 1 other identifier: 2024-519663-17-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bacterial Infections; Piperacillin/Tazobactam

Outcome Measures

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.

  Day 3

Secondary Outcomes (6)

• Achieving target concentrations

  Days 0, 1, 3, and 6

• Clinical cure at end of treatment

  Day 8

• Incidence of local and systemic adverse events

  Up to Day 9

• Health-related quality of life assessed by EQ-5D-5L

  Days 0, 3, and 9

• Patient-reported experience assessed by PREM questionnaire

  Day 9

Study Arms (2)

SC ARM

EXPERIMENTAL

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.

Device: Piperacillin, Tazobactam Drug Combination; Drug: Piperacillin, Tazobactam Drug Combination

IV ARM

ACTIVE COMPARATOR

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

Device: Piperacillin, Tazobactam Drug Combination; Drug: Piperacillin, Tazobactam Drug Combination

Interventions

Piperacillin, Tazobactam Drug Combination DEVICE

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.

Also known as: Piperacillin and tazobactam

IV ARM; SC ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Free, written and informed consent signed by the participant;
• 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;
• Evidence of postmenopausal status, defined as no menses for at least 12 consecutive months without an alternative medical cause and, if clinically indicated, confirmed by serum FSH levels in the postmenopausal range; or Negative serum pregnancy test at the screening visit (sensitivity ≥25 mIU/mL) and negative urine β-HCG test at the End-of-Treatment (D8) for females of childbearing potential who are sexually active with a non-sterilized male partner.
• Women of childbearing potential (WOCBP) are defined as all women who are not surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) and who are not postmenopausal;
• \- Admitted to one of the wards authorized for the enrollment.

You may not qualify if:

• 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;
• Known resistance to TZP;
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications;
• Participation in another clinical trial with administration of an investigational medicinal product (IMP) within 30 days prior to screening or within 5 half-lives of that IMP, whichever is longer.

Sponsors & Collaborators

• Azienda Sanitaria Universitaria Friuli Centrale: lead

Study Sites (1)

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italia/UD, 33100, Italy

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Carlo Tascini, Professor

  Azienda Sanitaria Universitaria Friuli Centrale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Tascini, Full Professor

CONTACT

+39-0432-559355; carlo.tascini@uniud.it

Chiara Moreal, MSn RN

CONTACT

+39-339-4091948; moreal.chiara@spes.uniud.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Piperacillin/tazobactam is administered as continuous infusion at a total daily dose of 18 g/day from D1 to D7 (end at D8), with renal dose adjustment according to protocol. Participants are randomized 1:1 on D0 to receive the study drug by either the subcutaneous route using a syringe pump or the intravenous route using a volumetric/electronic pump. The first 3 days of piperacillin/tazobactam treatment (D-2 to D0) are provided as standard of care before randomization. Treatment is followed by pharmacokinetic sampling and safety/clinical assessments according to the study schedule.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 19, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)