CLINICAL TRIALS PROFILE FOR PIPERACILLIN SODIUM

All Clinical Trials for Piperacillin Sodium

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.
NCT00389987 ↗	Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2001-09-01	This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
NCT00873327 ↗	Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates	Completed	Phillip Brian Smith	Phase 1	2009-10-01	This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each: 1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA) 2. < 32 weeks gestational age and >=14 days postnatal age 3. >=32 weeks gestational age and < 14 days postnatal age 4. >=32 weeks gestational age and >=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
NCT01370616 ↗	Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2011-09-02	This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections. The primary hypothesis was that treatment with ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in achieving clinical improvement or cure.
NCT01760109 ↗	Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection	Completed	Xiangbei Welman Pharmaceutical Co., Ltd	Phase 4	2011-07-01	In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
NCT01805856 ↗	Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery	Completed	Ito Hospital	N/A	2010-11-01	The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.

Clinical Trial Conditions for Piperacillin Sodium

Condition Name

Condition Name for Piperacillin Sodium
Intervention	Trials
Infection	2
Urinary Tract Infections	2
Respiratory Tract Infections	2
Thyroid Disease	1

Condition MeSH

Condition MeSH for Piperacillin Sodium
Intervention	Trials
Communicable Diseases	5
Infections	5
Infection	5
Urinary Tract Infections	2

Clinical Trial Locations for Piperacillin Sodium

Trials by Country

Trials by Country for Piperacillin Sodium
Location	Trials
United States	7
China	2
Canada	2
United Kingdom	1
Belgium	1

Trials by US State

Trials by US State for Piperacillin Sodium
Location	Trials
North Carolina	1
Missouri	1
Kansas	1
Indiana	1
Massachusetts	1

Clinical Trial Progress for Piperacillin Sodium

Clinical Trial Phase

Clinical Trial Phase for Piperacillin Sodium
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Piperacillin Sodium
Clinical Trial Phase	Trials
Completed	7
Unknown status	3
Not yet recruiting	1

Clinical Trial Sponsors for Piperacillin Sodium

Sponsor Name

Sponsor Name for Piperacillin Sodium
Sponsor	Trials
Merck Sharp & Dohme Corp.	2
Xiangbei Welman Pharmaceutical Co., Ltd	2
Haining Health-Coming Biotech Co., Ltd.	1

Sponsor Type

Sponsor Type for Piperacillin Sodium
Sponsor	Trials
Other	9
Industry	4

Piperacillin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Piperacillin sodium, a broad-spectrum antibiotic, has been a cornerstone in the treatment of various bacterial infections. This article delves into the current clinical trials, market analysis, and future projections for piperacillin sodium, providing a comprehensive overview of its significance and trends in the pharmaceutical industry.

Clinical Trials Update

COVID-19 and Other Infections

During the COVID-19 pandemic, several clinical trials have explored the use of piperacillin-tazobactam in combination with other antibiotics to treat severe infections. For instance, the Ottawa Hospital Research Institute conducted a trial combining piperacillin-tazobactam with macrolides for patients with COVID-19-associated acute respiratory distress syndrome (ARDS)[1].

Comparative Studies

A notable clinical trial is the one comparing EXBLIFEP (a combination of cefepime and enmetazobactam) with piperacillin-tazobactam. This multinational, double-blind, noninferiority trial involved 1,041 patients with complicated urinary tract infections (cUTI), including pyelonephritis. The results showed that EXBLIFEP was noninferior to piperacillin-tazobactam in terms of clinical and microbiological response[3].

Safety and Efficacy

The ACORN trial, another significant study, compared the safety of empiric therapy with cefepime versus piperacillin-tazobactam in patients with suspected infections. This trial found no association between the use of cefepime or piperacillin-tazobactam and the primary outcome of acute kidney injury[4].

Market Analysis

Current Market Size

The global piperacillin sodium market was estimated to be worth approximately USD 196.92 million in 2021. This market includes both piperacillin and its combination with tazobactam[2].

Market Segmentation

The market is segmented by type (piperacillin and piperacillin-tazobactam) and application (piperacillin sodium injection and compound injection). Key players such as Qilu Pharmaceutical, Pfizer Healthcare, Fresenius Kabi AG, and Aurobindo Pharma dominate the market landscape[2][5].

Regional Analysis

The market is distributed across various regions, including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth drivers[2].

Market Projections

Forecasted Growth

The global piperacillin sodium market is projected to reach USD 250.7 million by 2030, with a compound annual growth rate (CAGR) of 3.3% during the forecast period of 2022-2030. This growth is driven by increasing demand for broad-spectrum antibiotics and the expanding healthcare infrastructure in emerging markets[5].

Key Drivers

• Increasing Infections: The rise in bacterial infections, particularly those resistant to other antibiotics, drives the demand for piperacillin sodium.
• Advancements in Healthcare: Improvements in healthcare facilities and access to antibiotics in developing countries contribute to market growth.
• Competitive Landscape: The presence of multiple key players and their strategic initiatives to enhance product offerings and expand market reach also drive the market forward[2][5].

Competitive Landscape

Key Players

The market is highly competitive, with several major pharmaceutical companies involved. These include:

• Qilu Pharmaceutical
• Pfizer Healthcare
• Fresenius Kabi AG
• Aurobindo Pharma
• Sandoz Inc
• NCPC
• REYOUNG
• Yuhan Corporation
• LKPC
• Nectar Lifesciences
• Sterile India
• Suanfarma
• Rajasthan Antibiotics[2][5].

Strategies and Trends

Companies are focusing on expanding their product portfolios, enhancing manufacturing capabilities, and entering new markets. Strategic partnerships and collaborations are also common, aimed at improving market share and competitiveness[2][5].

Challenges and Restraints

Resistance and Side Effects

One of the significant challenges facing the piperacillin sodium market is the increasing resistance to antibiotics. Additionally, side effects such as acute kidney injury and other adverse reactions can impact market growth[4].

Regulatory Environment

Stringent regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can also pose challenges to market expansion[3].

Conclusion

Piperacillin sodium remains a vital antibiotic in the treatment of various bacterial infections. The ongoing clinical trials and comparative studies continue to validate its efficacy and safety profile. The market is expected to grow steadily, driven by increasing demand and advancements in healthcare infrastructure.

Key Takeaways

• Clinical Trials: Ongoing trials compare piperacillin-tazobactam with other antibiotics, ensuring its continued relevance.
• Market Size: The global market was valued at USD 196.92 million in 2021 and is projected to reach USD 250.7 million by 2030.
• Growth Drivers: Increasing infections, healthcare advancements, and competitive strategies drive market growth.
• Challenges: Antibiotic resistance and regulatory hurdles are key challenges.

FAQs

What is the current market size of piperacillin sodium?

The global piperacillin sodium market was estimated to be worth approximately USD 196.92 million in 2021[2].

What is the projected growth rate of the piperacillin sodium market?

The market is expected to grow at a CAGR of 3.3% from 2022 to 2030, reaching USD 250.7 million by 2030[5].

Who are the key players in the piperacillin sodium market?

Key players include Qilu Pharmaceutical, Pfizer Healthcare, Fresenius Kabi AG, Aurobindo Pharma, and several others[2][5].

What are the main applications of piperacillin sodium?

The main applications include piperacillin sodium injection and compound injection, used to treat various bacterial infections[2].

What are the challenges facing the piperacillin sodium market?

Challenges include increasing antibiotic resistance, side effects such as acute kidney injury, and stringent regulatory requirements[4].

How does the competitive landscape of the piperacillin sodium market look?

The market is highly competitive with multiple key players focusing on product expansion, manufacturing enhancements, and strategic partnerships[2][5].

Sources

1. COVID-19 Clinical Trials - Ottawa Hospital Research Institute, Pharmacology Canada.
2. Global Piperacillin Sodium Market Report 2022 - ResearchAndMarkets.com.
3. Drug Trials Snapshots: EXBLIFEP - FDA.
4. Nut Cracked? Does the ACORN Trial End the Debate Surrounding ... - Oxford Academic.
5. Piperacillin Sodium Market Size, Share, Growth, Trends, Report ... - BioSpace.