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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519663-17-01 | EU Trial (CTIS) Number |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 0, 1, 3, and 6 |
| Clinical cure at end of treatment |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Tascini, Professor | Azienda Sanitaria Universitaria Friuli Centrale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria Universitaria Friuli Centrale | Recruiting | Udine | Italia/UD | 33100 | Italy |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
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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.
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| Piperacillin, Tazobactam Drug Combination | Drug | 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. |
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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. |
| 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. | 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. | Days 0, 3, and 9 |
| Patient-reported experience assessed by PREM questionnaire | Patient-reported experience assessed using the study PREM questionnaire. | 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. | Through study completion |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |