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

NCT06972537 | Recruiting

• 1 other identifier: SDU-2024-PIP-002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Empirical regimen

ACTIVE COMPARATOR

Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, administered every 8 hours, with each infusion lasting for 3 hours

Drug: Extended Infusion Time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g

Prolonged infusion time

EXPERIMENTAL

Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g, administered every 6 hours, with each infusion lasting for 4 hours

Drug: Increase the frequency and extended infusion time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g

Interventions

Increase the frequency and extended infusion time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g DRUG

Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g administered four times a day (QID), with each infusion lasting for 4 hours.

Prolonged infusion time

Extended Infusion Time of Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g DRUG

Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda), 4.5g administered three times a day (TID), with each infusion lasting for 3 hours.

Empirical regimen

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of allergy to β-lactam antibiotics Continuous renal replacement therapy, severe organ dysfunction Malignant tumor disease

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Second hospital of Shandong university

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

Tazobactam; Injections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 15, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)