Pneumonia
Conditions
Brief 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.
Interventions
DRUGIncrease 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.
DRUGExtended 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.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement rate | 3 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| PK/PD target attainment rate | 2 days |
| 28-day mortality rate | 3 months |
| 7-day microbiological clearance rate | after 7days when finished infuse piperacillin |
| Length of Hospital Stay ICU and Length of ICU Stay | Up to 24 weeks |
Countries
China
Contacts
Primary ContactWei Zhao, Ph.D
Outcome results
None listed