Bacteria InfectionPhase 2STUPITA01NCT07481539
Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment
A Phase 2 study testing Piperacillin, Tazobactam Drug Combination in people with Bacteria Infection and Piperacillin, Tazobactam Drug Combination, run by Azienda Sanitaria Universitaria Friuli Centrale at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteria Infection, Piperacillin, Tazobactam Drug Combination
- What is being tested?
- Piperacillin, Tazobactam Drug Combination
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2026to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italia/UD, 33100
Carlo Tascini, Professor, +39-0432-559355, carlo.tascini@uniud.it
About this study
Official title: Evaluation of the Pharmacokinetics of Subcutaneous Administration of Piperacillin/Tazobactam: an Open-Label, Multicentric, Non-inferiority Randomized Clinical 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.
Read more
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
- Being tested
- Piperacillin, Tazobactam Drug Combination
- Keywords
- Bacterial Infections, Piperacillin/Tazobactam
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin, Tazobactam Drug CombinationDevice
Also called Piperacillin and tazobactam
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.
Piperacillin, Tazobactam Drug CombinationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Piperacillin, Tazobactam Drug Combination; Drug: Piperacillin, Tazobactam Drug Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3
Secondary outcomes (6)
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.
Measured: Days 0, 1, 3, and 6
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.
Measured: Day 8
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.
Measured: Up to Day 9
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.
Measured: Days 0, 3, and 9
Patient-reported experience assessed by PREM questionnaire
Patient-reported experience assessed using the study PREM questionnaire.
Measured: Day 9
Perception of nurses
Nurses' perceptions of subcutaneous versus intravenous administration of piperacillin/tazobactam explored through semi-structured interviews addressing ease of administration, perceived benefits and challenges, patient responses, and logistical or technical issues.
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start24 Mar 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteria InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Universitaria Friuli Centrale
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, carlo.tascini@uniud.it, Azienda Sanitaria Universitaria Friuli Centrale
- Investigators
- Carlo Tascini, Professor, Principal investigator, Azienda Sanitaria Universitaria Friuli Centrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481539
- Sponsor's protocol ID
- 2024-519663-17-01
- Other IDs
- 2024-519663-17-01
- Acronym
- STUPITA01
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics of Subcutaneous Administration of Piperacillin/Tazobactam: an Open-Label, Multicentric, Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07481539
- Acronym / sponsor ID
- STUPITA01 / 2024-519663-17-01
- Keywords
- Bacterial Infections, Piperacillin/Tazobactam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Universitaria Friuli CentraleUniversity, hospital or other
- Study start
- 24 Mar 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SC ARM | Experimental | Device: Piperacillin, Tazobactam Drug Combination, Drug: Piperacillin, Tazobactam Drug CombinationParticipants 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. |
| IV ARM | Active comparator | Device: Piperacillin, Tazobactam Drug Combination, Drug: Piperacillin, Tazobactam Drug CombinationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin, Tazobactam Drug CombinationAlso: Piperacillin and tazobactamParticipants 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 | IV ARM, SC ARM |
| Piperacillin, Tazobactam Drug CombinationParticipants 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. | Drug | IV ARM, SC ARM |
Primary outcome
PK profile
Time frame: Day 3
Area under the plasma concentration-time curve (AUC) of piperacillin/tazobactam measured from plasma antibiotic concentrations collected for pharmacokinetic assessment at steady state.
6 secondary outcomes
Achieving target concentrations
Time frame: Days 0, 1, 3, and 6
Clinical cure at end of treatment
Time frame: Day 8
Incidence of local and systemic adverse events
Time frame: Up to Day 9
Health-related quality of life assessed by EQ-5D-5L
Time frame: Days 0, 3, and 9
Patient-reported experience assessed by PREM questionnaire
Time frame: Day 9
Perception of nurses
Time frame: Through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo Tascini, Professor principal investigator
Azienda Sanitaria Universitaria Friuli Centrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Piperacillin, Tazobactam Drug Combination in people with Bacteria Infection and Piperacillin, Tazobactam Drug Combination, run by Azienda Sanitaria Universitaria Friuli Centrale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Tascini, Full Professor (+39-0432-559355, carlo.tascini@uniud.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK profile (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.