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NCT Number: NCT06972537

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

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second hospital of Shandong university

Jinan, Shandong, 250000, China

Location status: Recruiting

Location contact

Jing Sun

CONTACT

[email protected]

86053185875490

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Clinical improvement rate

    Time frame: 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 outcomes

  1. PK/PD target attainment rate

    Time frame: 2 days

  2. 28-day mortality rate

    Time frame: 3 months

  3. 7-day microbiological clearance rate

    Time frame: after 7days when finished infuse piperacillin

  4. Length of Hospital Stay ICU and Length of ICU Stay

    Time frame: Up to 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhao, Ph.D

CONTACT

[email protected]

86053188383308

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Model-Guided Dose Optimization vs. Empirical Dosing of Piperacillin-Tazobactam in the Treatment of Pneumonia in Elderly Patients: A Study on Superiority

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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