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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR PIPERACILLIN AND TAZOBACTAM


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All Clinical Trials for Piperacillin And Tazobactam

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003805 ↗ Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1997-11-01 RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00044746 ↗ Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 4 2000-10-01 Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.
NCT00044759 ↗ Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 1969-12-31 To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Piperacillin And Tazobactam

Condition Name

Condition Name for Piperacillin And Tazobactam
Intervention Trials
Sepsis 5
Septic Shock 5
Pneumonia 4
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Condition MeSH

Condition MeSH for Piperacillin And Tazobactam
Intervention Trials
Infections 25
Infection 23
Communicable Diseases 17
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Clinical Trial Locations for Piperacillin And Tazobactam

Trials by Country

Trials by Country for Piperacillin And Tazobactam
Location Trials
United States 121
China 23
Italy 16
Germany 15
France 15
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Trials by US State

Trials by US State for Piperacillin And Tazobactam
Location Trials
Texas 8
Florida 8
California 7
Missouri 6
New York 5
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Clinical Trial Progress for Piperacillin And Tazobactam

Clinical Trial Phase

Clinical Trial Phase for Piperacillin And Tazobactam
Clinical Trial Phase Trials
Phase 4 29
Phase 3 24
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Piperacillin And Tazobactam
Clinical Trial Phase Trials
Completed 43
Not yet recruiting 12
Unknown status 11
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Clinical Trial Sponsors for Piperacillin And Tazobactam

Sponsor Name

Sponsor Name for Piperacillin And Tazobactam
Sponsor Trials
Merck Sharp & Dohme Corp. 9
Wyeth is now a wholly owned subsidiary of Pfizer 8
M.D. Anderson Cancer Center 5
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Sponsor Type

Sponsor Type for Piperacillin And Tazobactam
Sponsor Trials
Other 157
Industry 43
U.S. Fed 2
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Piperacillin and Tazobactam: Clinical Trials, Market Analysis, and Projections

Introduction

Piperacillin and tazobactam is a potent combination antibiotic used to treat serious bacterial infections, including complicated intra-abdominal infections and pneumonia. This article delves into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials: Efficacy and Safety

Comparison with Other Antibiotics

A recent clinical trial compared the efficacy of piperacillin/tazobactam with another antibiotic combination, EXBLIFEP (cefepime and enmetazobactam). The trial demonstrated that EXBLIFEP was noninferior to piperacillin/tazobactam in treating bacterial infections. Patients were randomized into two groups, with 345 patients receiving EXBLIFEP and 333 patients receiving piperacillin/tazobactam. The primary efficacy endpoint showed that 79% of patients in the EXBLIFEP group and 59% in the piperacillin/tazobactam group achieved clinical cure and microbiological response[1].

Personalized Dosing in Critically Ill Patients

Another study focused on the therapeutic exposure of piperacillin in critically ill patients with sepsis or septic shock. The study highlighted the importance of personalized dosing using software-guided empiric dosing and therapeutic drug monitoring (TDM). This approach significantly enhanced therapeutic exposure and reduced potentially harmful concentrations of piperacillin. The study found that 89% of patients achieved the minimum therapeutic exposure, and subsequent TDM-guided dose adjustments improved this to 65%[3].

Risk of Acute Kidney Injury and Neurological Effects

The Antibiotic Choice on Renal Outcomes (ACORN) trial compared cefepime with piperacillin/tazobactam in adults hospitalized with suspected infections. This trial assessed the risk of acute kidney injury and neurological effects associated with these antibiotics. While the trial did not specifically focus on piperacillin/tazobactam alone, it provided valuable insights into the comparative safety profiles of these antibiotics in clinical settings[4].

Market Analysis

Global Market Size and Growth

The global market for piperacillin and tazobactam injection is projected to grow steadily. As of 2023, the market was estimated to be worth US$ 217 million and is forecasted to reach US$ 247.7 million by 2030, with a Compound Annual Growth Rate (CAGR) of 1.0% during the forecast period[5].

Market Segmentation

The market is segmented by type (piperacillin injection and tazobactam injection) and by application (hospital and clinic settings). The report also analyzes the market by region, including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Key manufacturers such as Qilu Pharmaceutical, Pfizer Healthcare, Fresenius Kabi AG, and Aurobindo Pharma are identified as major players in this market[2][5].

Competitive Landscape

The competitive landscape of the piperacillin and tazobactam market is characterized by several key players. These companies are focused on enhancing their market share through strategic developments, mergers, and acquisitions. The report provides a detailed analysis of the competitive landscape, market positioning, and recent developments of these manufacturers[2].

Market Projections

Forecasted Growth

The global piperacillin and tazobactam API market is expected to grow at a CAGR of 1.0% from 2024 to 2030. This growth is driven by the increasing demand for effective antibiotics to treat complicated infections, particularly in the context of rising antibiotic resistance[5].

Regional Focus

The market is expected to see significant growth in regions such as Asia Pacific, driven by the large patient population and increasing healthcare expenditure. Countries like China, India, and Japan are anticipated to be key markets due to their growing healthcare needs and infrastructure development[2].

Impact of COVID-19

The COVID-19 pandemic has highlighted the importance of robust healthcare systems and the need for effective antibiotics. This has accelerated the development and supply of critical medications, including piperacillin and tazobactam, further emphasizing the market's potential for growth[2].

Key Takeaways

  • Clinical Efficacy: Piperacillin/tazobactam has been shown to be effective in treating serious bacterial infections, with clinical trials demonstrating its noninferiority to other antibiotic combinations.
  • Personalized Dosing: Personalized dosing strategies can significantly improve the therapeutic exposure of piperacillin in critically ill patients.
  • Market Growth: The global market for piperacillin and tazobactam is projected to grow at a CAGR of 1.0% from 2024 to 2030, driven by increasing demand and healthcare infrastructure development.
  • Competitive Landscape: The market is competitive, with several key players focusing on strategic developments and market positioning.

FAQs

What is the primary use of piperacillin and tazobactam?

Piperacillin and tazobactam is a combination antibiotic used to treat serious bacterial infections, including complicated intra-abdominal infections and pneumonia.

How does piperacillin/tazobactam compare to other antibiotics in clinical trials?

Recent clinical trials have shown that piperacillin/tazobactam is noninferior to other antibiotic combinations like EXBLIFEP in treating bacterial infections.

What is the impact of personalized dosing on piperacillin therapy in critically ill patients?

Personalized dosing using software-guided empiric dosing and therapeutic drug monitoring (TDM) significantly enhances therapeutic exposure and reduces potentially harmful concentrations of piperacillin in critically ill patients.

What is the projected market size for piperacillin and tazobactam by 2030?

The global market for piperacillin and tazobactam API is forecasted to reach US$ 247.7 million by 2030.

Which regions are expected to drive the growth of the piperacillin and tazobactam market?

The Asia Pacific region, particularly countries like China, India, and Japan, is expected to drive significant growth due to increasing healthcare needs and infrastructure development.

Sources

  1. FDA: Drug Trials Snapshots: EXBLIFEP - FDA.
  2. QYResearch: Global Piperacillin and tazobactam Injection Market Insights, Forecast to 2030.
  3. MDPI: Personalized Piperacillin Dosing for the Critically Ill.
  4. JAMA Network: Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized With Suspected Infections.
  5. Valuates Reports: Piperacillin and Tazobactam API - Market Size.

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