A Study on the Infusion Regimen of Piperacillin-Tazobactam in Patients Aged 65 and Older With Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Increase the frequency and extended infusion time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, Extended Infusion Time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g.
- Who it may be relevant to
- Registry conditions: Pneumonia. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Model-Guided Dose Optimization vs. Empirical Dosing of Piperacillin-Tazobactam in the Treatment of Pneumonia in Elderly Patients: A Study on Superiority
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.
Interventions
- 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.
Primary outcome measures
- Clinical improvement rate [Time frame: 3 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Second hospital of Shandong university — Jinan
Identifiers
NCT: NCT06972537 · SDU-2024-PIP-002