Evaluation of the Pharmacokinetics of Subcutaneous Administration of Piperacillin/Tazobactam: An Open-Label, Multicentric, Non-Inferiority Randomized Clinical Trial (STUPITA01)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Sanitaria Universitaria Friuli Centrale

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Phenomena and Processes [G] - Microbiological Phenomena [G06], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Decision date (initial)

2026-01-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

To evaluate the non-inferiority of the PK profile of TZP when administered subcutaneously as compared to the standard IV route.

Secondary objectives 1

1. - To assess the non-inferiority of SC versus IV administration of TZP in achieving target concentrations based on PK/PD clinical breakpoints; - To compare the efficacy of SC versus intravenous administration of TZP in treating bacterial infections; - To assess the safety and tolerability in the administration of TZP; - To assess the evolution of infection as clinical response up to EOT; - To assess the treatment failure up to EOT; - To evaluate patient satisfaction and experience with SC administration compared to IV administration; - To explore the perception of nurses in SC vs IV administration of TZP.

Conditions and MedDRA coding

Infectious disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Subjects must meet ALL the following inclusion criteria: - 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 (D9) 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.

Exclusion criteria 1

1. Subjects must NOT meet any of the following exclusion criteria to qualify for the study: - 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The area under the plasma concentration-time curve (AUC) of TZP, demonstrating that TZP administration is non-inferior to IV administration. PK profile will be evaluated through the plasma antibiotic concentrations, obtained by sample collection.

Secondary endpoints 1

1. -Therapeutic drug monitoring of piperacillin to ensure target concentrations non-inferior than or equal to 40 mg/L between groups, aligning with established PK/PD clinical breakpoints established; - Clinical cure rate at the end of the treatment period, defined as the partial or complete resolution of clinical signs and symptoms of infection without the need for additional antibiotic therapy; -Microbiologic success rate at EOT; - Incidence of AEs: occurrences of AEs up to 1 day after the end

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Sanitaria Universitaria Friuli Centrale

Sponsor organisation

Azienda Sanitaria Universitaria Friuli Centrale

Address

Piazzale Santa Maria Della Misericordia 15

City

Udine

Postcode

33100

Country

Italy

Scientific contact point

Organisation

Azienda Sanitaria Universitaria Friuli Centrale

Contact name

Prof. Carlo Tascini

Public contact point

Organisation

Azienda Sanitaria Universitaria Friuli Centrale

Contact name

Dott.ssa Samantha Gomboso

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications