Actively Recruiting
Model-Guided Dose Optimization vs. Empirical Dosing of Piperacillin-Tazobactam in the Treatment of Pneumonia in Elderly Patients: A Study on Superiority
Led by Shandong University · Updated on 2025-05-15
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the infusion regimens of the antibiotic Piperacillin-Tazobactam in elderly patients aged 65 and older who have pneumonia. This study focuses on comparing two different dosing schedules to understand which infusion method better achieves the desired drug concentration for treating pneumonia effectively in this age group. The goal is to provide evidence that can guide clinical practice for this vulnerable population. The study compares two treatment groups: one receiving Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g every 8 hours with each infusion lasting 3 hours, and the other receiving the same drug every 6 hours with each infusion lasting 4 hours. These different infusion schedules are being assessed to determine their impact on drug levels in the body and clinical outcomes. Participants will receive the assigned infusion regimen and undergo monitoring during the study period. Researchers will evaluate the clinical improvement rate after 3 months as the primary outcome. Secondary outcomes include the pharmacokinetic/pharmacodynamic target attainment within 2 days, 28-day mortality rate, 7-day microbiological clearance rate, and the length of hospital and ICU stays up to 24 weeks. This comprehensive assessment will help understand the effectiveness and safety of the infusion regimens in elderly pneumonia patients.
CONDITIONS
Brief Title
A Study on the Infusion Regimen of Piperacillin-Tazobactam in Patients Aged 65 and Older With Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age must be greater than 65 years
- Clinical diagnosis of Pneumonia
- Receiving intravenous piperacillin-tazobactam treatment
You will not qualify if you...
- History of allergy to beta-lactam antibiotics
- Continuous renal replacement therapy or severe organ dysfunction
- Malignant tumor disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive Piperacillin Sodium and Tazobactam Sodium infusions according to their assigned regimen to treat pneumonia.
Daily infusions with 3 to 4 hour infusion times, administered either three or four times a day depending on regimen
Duration - Up to 3 months
Participants are monitored for clinical improvement, microbiological clearance, and other outcomes after treatment ends.
Follow-up visits over 3 months to assess clinical improvement and survival
Trial Site Locations
Total: 1 location
1
Second hospital of Shandong university
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
W
Wei Zhao, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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