A Study on the Infusion Regimen of Piperacillin-Tazobactam in Patients Aged 65 and Older With Pneumonia

Shandong University

Status: Enrolling

Conditions: Pneumonia

Treatments: Drug: Extended Infusion Time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g; Drug: Increase the frequency and extended infusion time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g

Study type: Interventional

Funder types: Other

Identifiers

NCT06972537

SDU-2024-PIP-002

Details and patient eligibility

About

Pneumonia is characterized by high incidence and mortality rates in elderly patients (≥65 years old). Piperacillin-tazobactam, as a broad-spectrum antibiotic, has its therapeutic efficacy and safety potentially influenced by the infusion regimen. However, research on infusion regimens specifically targeting the elderly population is currently limited. In our preliminary dose simulation, under the pharmacokinetic/pharmacodynamic (PK/PD) target of achieving a free drug concentration time percentage above 100% of the minimum inhibitory concentration (fT%>100% MIC), the regimen of administering the drug every 6 hours (q6h) achieved a concentration compliance rate of 90% within 4 hours. This study aims to explore the differences between two infusion modes (q6h for 4 hours vs. q8h for 3 hours) and to provide preliminary evidence for clinical practice.

Enrollment: 42 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age must be greater than 65 years Clinical diagnosis of Pneumonia Receiving intravenous piperacillin-tazobactam treatment

Exclusion criteria

History of allergy to β-lactam antibiotics Continuous renal replacement therapy, severe organ dysfunction Malignant tumor disease

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

Empirical regimen

Active Comparator group

Description:

Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, administered every 8 hours, with each infusion lasting for 3 hours

Treatment:

Drug: Extended Infusion Time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g

Prolonged infusion time

Experimental group

Description:

Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, administered every 6 hours, with each infusion lasting for 4 hours

Treatment:

Drug: Increase the frequency and extended infusion time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g