NCT06972537

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

Model-Guided Dose Optimization vs. Empirical Dosing of Piperacillin-Tazobactam in the Treatment of Pneumonia in Elderly Patients: A Study on Superiority

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Increase the frequency and extended infusion time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g	Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g administered four times a day (QID), with each infusion lasting for 4 hours.
DRUG	Extended Infusion Time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g	Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g administered three times a day (TID), with each infusion lasting for 3 hours.

Timeline

• Start date: 2024-07-24
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: China