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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 100
Healthy Volunteers: f
View:

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

Locations
Other Locations
China
Second hospital of Shandong university
RECRUITING
Jinan
Contact Information
Primary
Wei Zhao, Ph.D
zhao4wei2@hotmail.com
86053188383308
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 42
Treatments
Active_comparator: Empirical regimen
Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, administered every 8 hours, with each infusion lasting for 3 hours
Experimental: Prolonged infusion time
Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, administered every 6 hours, with each infusion lasting for 4 hours
Related Therapeutic Areas
Sponsors
Leads: Shandong University

This content was sourced from clinicaltrials.gov

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