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

NCT ID: NCT06972537

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-24

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Empirical regimen

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Prolonged infusion time

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second hospital of Shandong university

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Ph.D

Role: CONTACT

[email protected]
86053188383308

Facility Contacts

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Jing Sun

Role: primary

[email protected]
86053185875490

Other Identifiers

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SDU-2024-PIP-002

Identifier Type: -

Identifier Source: org_study_id

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