2024-519663-17-01招募中2 期
Evaluation of the Pharmacokinetics of Subcutaneous Administration of Piperacillin/Tazobactam: An Open-Label, Multicentric, Non-Inferiority Randomized Clinical Trial (STUPITA01)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
To evaluate the non-inferiority of the PK profile of TZP when administered subcutaneously as compared to the standard IV route.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
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.
次要结局
- -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
研究者
Prof. Carlo Tascini
Scientific
Azienda Sanitaria Universitaria Friuli Centrale
研究点 (2)
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