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Last Updated: March 14, 2025

CLINICAL TRIALS PROFILE FOR PIPERACILLIN SODIUM; TAZOBACTAM SODIUM


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All Clinical Trials for piperacillin sodium; tazobactam sodium

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for piperacillin sodium; tazobactam sodium

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1InfectionInfection; Diabetic FootMalignant Solid Neoplasm[disabled in preview]
Condition Name for piperacillin sodium; tazobactam sodium
Intervention Trials
Infection 1
Infection; Diabetic Foot 1
Malignant Solid Neoplasm 1
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Condition MeSH

2220-0.200.20.40.60.811.21.41.61.822.2InfectionsInfectionCommunicable Diseases[disabled in preview]
Condition MeSH for piperacillin sodium; tazobactam sodium
Intervention Trials
Infections 2
Infection 2
Communicable Diseases 2
[disabled in preview] 0
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Clinical Trial Locations for piperacillin sodium; tazobactam sodium

Trials by Country

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Trials by Country for piperacillin sodium; tazobactam sodium
Location Trials
United States 5
Canada 1
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Trials by US State

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Trials by US State for piperacillin sodium; tazobactam sodium
Location Trials
Texas 1
North Carolina 1
Missouri 1
Kansas 1
Indiana 1
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Clinical Trial Progress for piperacillin sodium; tazobactam sodium

Clinical Trial Phase

40.0%20.0%40.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 3Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for piperacillin sodium; tazobactam sodium
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1 2
[disabled in preview] 0
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Clinical Trial Status

60.0%20.0%20.0%000.511.522.53CompletedNot yet recruitingUnknown status[disabled in preview]
Clinical Trial Status for piperacillin sodium; tazobactam sodium
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for piperacillin sodium; tazobactam sodium

Sponsor Name

trials000111112222Merck Sharp & Dohme Corp.St. Justine's HospitalM.D. Anderson Cancer Center[disabled in preview]
Sponsor Name for piperacillin sodium; tazobactam sodium
Sponsor Trials
Merck Sharp & Dohme Corp. 2
St. Justine's Hospital 1
M.D. Anderson Cancer Center 1
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Sponsor Type

60.0%40.0%000.511.522.53OtherIndustry[disabled in preview]
Sponsor Type for piperacillin sodium; tazobactam sodium
Sponsor Trials
Other 3
Industry 2
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Piperacillin/Tazobactam: Clinical Trials, Market Analysis, and Projections

Introduction

Piperacillin/tazobactam, a combination of the beta-lactam antibiotic piperacillin and the beta-lactamase inhibitor tazobactam, is a widely used antimicrobial agent. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Broad Spectrum of Activity

Piperacillin/tazobactam has a broad spectrum of antibacterial activity, encompassing most Gram-positive and Gram-negative aerobic and anaerobic bacteria, including many pathogens that produce beta-lactamases[3].

Clinical Outcomes

Clinical trials have shown that piperacillin/tazobactam is highly effective in treating various infections, including lower respiratory tract, intra-abdominal, urinary tract, gynaecological, and skin/soft tissue infections. It has also been effective in treating fever in patients with neutropenia. In comparisons with other antibiotics, piperacillin/tazobactam has often demonstrated superior clinical and microbiological outcomes. For instance, it was more effective than ticarcillin/clavulanic acid in treating community-acquired pneumonia and intra-abdominal infections[3].

Combination Therapies

Piperacillin/tazobactam is often used in combination with other antibiotics, such as aminoglycosides, to treat severe nosocomial infections. In these combinations, it has shown efficacy comparable to or better than other treatment regimens. For example, piperacillin/tazobactam plus amikacin was at least as effective as ceftazidime plus amikacin in treating ventilator-associated pneumonia[3].

Pediatric Use

In children, piperacillin/tazobactam is used to treat lower respiratory tract bacterial infections, although current dosing regimens may result in subtherapeutic plasma concentrations. Studies suggest that the dosing regimen may need adjustment to achieve optimal therapeutic levels[4].

Market Analysis

Global Market Size and Growth

The global market for piperacillin sodium preparations, including piperacillin/tazobactam, was valued at approximately $1.2 billion in 2022 and is projected to reach around $1.8 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 8.5% during the forecast period. This growth is driven by the increasing prevalence of bacterial infections and the growing demand for effective antibiotics[2].

Market Segmentation

The market is segmented by product type (single preparation, piperacillin+sulbactam, piperacillin+tazobactam) and by end-user/application (hospital, clinic, others). Each segment shows distinct growth trends influenced by consumer preferences, technological advancements, and regulatory frameworks. The demand for piperacillin+tazobactam is particularly strong due to its broad spectrum of activity and effectiveness in treating various infections[2].

Regional Analysis

The market is analyzed across key regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Asia-Pacific is the fastest-growing region, fueled by rapid industrialization, urbanization, and an expanding consumer base. North America and Europe are mature markets with high adoption rates of innovative technologies and significant R&D investments[2].

Key Players and Manufacturing

The global tazobactam sodium market involves several key players, including Tecoland, Dynalabs, Iffect Chemphar, Qilu Pharmaceutical, Cayman Chem, Zhejiang Happy Chemical, Dawnrays, and Hubei Widely Chemical. These companies are involved in the production and distribution of tazobactam sodium, which is a critical component of the piperacillin/tazobactam combination[5].

Future Projections

Market Growth Drivers

The market for piperacillin/tazobactam is expected to continue growing due to several factors:

  • Increasing Prevalence of Bacterial Infections: The rise in antibiotic-resistant bacteria and the need for effective treatments drive the demand for broad-spectrum antibiotics like piperacillin/tazobactam.
  • Advancements in Pharmaceutical Manufacturing: Improvements in manufacturing processes and the development of more efficient production methods are expected to enhance market growth.
  • Expanding Healthcare Infrastructure: Growing healthcare infrastructure in emerging markets, particularly in Asia-Pacific, will increase the demand for piperacillin/tazobactam[2].

Challenges and Opportunities

Despite the positive outlook, there are challenges to consider:

  • Antibiotic Resistance: The ongoing issue of antibiotic resistance may necessitate the development of new formulations or combination therapies.
  • Regulatory Frameworks: Stricter regulatory environments, especially in regions like Europe, can impact market dynamics.
  • Pediatric Dosing: The need for optimized dosing regimens in pediatric patients presents an opportunity for further research and development[4].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Piperacillin/tazobactam is generally well-tolerated, but common adverse reactions include gastrointestinal symptoms (such as diarrhea), skin reactions, and local reactions. The incidence of adverse events can be higher when the combination is given with other antibiotics like aminoglycosides[3].

Serious Adverse Reactions

Rare but serious adverse reactions include C. difficile-associated diarrhea, hemophagocytic lymphohistiocytosis, and bleeding. Monitoring for these conditions is crucial, especially in vulnerable patient populations[1].

Key Takeaways

  • Broad Spectrum of Activity: Piperacillin/tazobactam is effective against a wide range of Gram-positive and Gram-negative bacteria.
  • Clinical Efficacy: It has shown superior clinical and microbiological outcomes in various infections compared to other antibiotics.
  • Market Growth: The global market for piperacillin sodium preparations is projected to grow significantly, driven by increasing bacterial infections and advancements in manufacturing.
  • Regional Variations: The market growth varies by region, with Asia-Pacific being the fastest-growing.
  • Challenges and Opportunities: The market faces challenges such as antibiotic resistance and regulatory frameworks, but also presents opportunities for further research and development.

FAQs

What is the mechanism of action of piperacillin/tazobactam?

Piperacillin is active against a variety of bacteria, while tazobactam inhibits beta-lactamase enzymes, thereby protecting piperacillin from degradation[1].

What are the common indications for piperacillin/tazobactam?

It is used to treat lower respiratory tract, intra-abdominal, urinary tract, gynaecological, and skin/soft tissue infections, as well as fever in patients with neutropenia[3].

What are the potential adverse reactions of piperacillin/tazobactam?

Common adverse reactions include gastrointestinal symptoms, skin reactions, and local reactions. Rare but serious reactions include C. difficile-associated diarrhea and hemophagocytic lymphohistiocytosis[1].

How is the market for piperacillin/tazobactam segmented?

The market is segmented by product type (single preparation, piperacillin+sulbactam, piperacillin+tazobactam) and by end-user/application (hospital, clinic, others)[2].

What are the key drivers of the market growth for piperacillin/tazobactam?

The market growth is driven by the increasing prevalence of bacterial infections, advancements in pharmaceutical manufacturing, and expanding healthcare infrastructure[2].

Which regions are expected to see the most significant growth in the piperacillin/tazobactam market?

Asia-Pacific is expected to be the fastest-growing region, followed by North America and Europe[2].

Sources

  1. Piperacillin/Tazobactam Prescription & Dosage Information - MPR
  2. Insight-Data-Vista/Piperacillin Sodium Preparations Market.md - GitHub
  3. An updated review of its use in the treatment of bacterial infections - PubMed
  4. Piperacillin/tazobactam treatment in children: evidence of ... - Frontiers
  5. Global Tazobactam Sodium Market Research Report 2024 - Valuates Reports

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