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

Shandong University42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pneumonia

Interventions

Eligibility

Sex: ALLMin age: 65 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical improvement rate

Improvement in pneumonia symptoms, such as normalization of body temperature (temperature reduced to 37.8°C or below and maintained for 48 hours), alleviation of symptoms (coughing subsides, sputum production decreases, dyspnea eases, respiratory rate drops to below 24 breaths per minute, and other symptoms such as fatigue and chest pain significantly improve), improvement in physical signs (heart rate decreases to below 100 beats per minute, and wet rales on lung auscultation diminish or disappear), improvement in laboratory tests (white blood cell count returns to normal or near-normal levels, and levels of inflammatory markers such as C-reactive protein and procalcitonin decline), and radiological improvement (chest X-ray or CT shows absorption of pulmonary inflammation and reduction in the extent of lesions), as well as the Apache II score.

Time frame: 3 months

Secondary Outcomes

PK/PD target attainment rate

Time frame: 2 days

28-day mortality rate

Time frame: 3 months

7-day microbiological clearance rate

Time frame: after 7days when finished infuse piperacillin

Length of Hospital Stay ICU and Length of ICU Stay

Time frame: Up to 24 weeks