Piperacillin; Tazobactam for Bacterial infection|Infectious disease

Inclusion criteria

• {"criterion_text":"- Free, written and informed consent signed by the participant;\n- At least 18 years old on the day of inclusion;\n- Male and female participants;\n- 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;\n- 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;\n- Admitted to one of the wards authorized for the enrollment."}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to penicillins, cephalosporins, other β-lactamase inhibitors, or any component of the formulation;\n- Pregnant or breastfeeding women, and women intending to become pregnant during the study or within the End-of-Treatment visit;\n- 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;\n- No indication for treatment with TZP;\n- Known resistance to TZP;\n- 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;\n- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"PK profile evaluated through plasma antibiotic concentrations obtained by sample collection; primary measure is AUC of TZP to demonstrate non-inferiority versus IV."}

Secondary endpoints

• {"endpoint_text":"- 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;","definition_or_measurement_approach":"Therapeutic drug monitoring measuring piperacillin concentrations; target concentration ≥40 mg/L; comparison between SC and IV groups."}
• {"endpoint_text":"- 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;","definition_or_measurement_approach":"Clinical assessment at End-of-Treatment to determine partial or complete resolution of signs/symptoms and absence of need for additional antibiotic therapy."}
• {"endpoint_text":"- Microbiologic success rate at EOT;","definition_or_measurement_approach":"Microbiologic success assessed at End-of-Treatment (EOT); specific microbiologic criteria not detailed in provided text."}
• {"endpoint_text":"- Incidence of AEs: occurrences of AEs up to 1 day after the end","definition_or_measurement_approach":"Recording and counting adverse events occurring up to 1 day after End-of-Treatment."}

Methods

• Recruitment of patients admitted to participating hospital wards authorised for enrollment; patients identified and enrolled by site investigators at participating hospital/clinic sites.

Italy

Earliest CTIS Part Ii Submission Date

15-11-2025

Latest Decision Or Authorization Date

09-01-2026

Processing Time Days

55

Number Of Sites

2

Number Of Participants

240

Primary sponsor

Full Name

Azienda Sanitaria Universitaria Friuli Centrale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy