CLINICAL TRIALS PROFILE FOR PIPERACILLIN AND TAZOBACTAM

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.
NCT00167999 ↗	Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units	Completed	Wyeth is now a wholly owned subsidiary of Pfizer		2005-02-01	To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units
NCT00195286 ↗	Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.	Completed	Wyeth is now a wholly owned subsidiary of Pfizer		2004-06-01	The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections
NCT00195533 ↗	Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients	Completed	PETHEMA (Program for the Study and Treatment of Haematological Malignances)		2001-07-01	The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.
NCT00195533 ↗	Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients	Completed	Wyeth is now a wholly owned subsidiary of Pfizer		2001-07-01	The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.

Clinical Trial Conditions for PIPERACILLIN AND TAZOBACTAM

Condition Name

Condition Name for PIPERACILLIN AND TAZOBACTAM
Intervention	Trials
Sepsis	6
Septic Shock	5
Pneumonia	5
Enterobacteriaceae Infections	4

Condition MeSH

Condition MeSH for PIPERACILLIN AND TAZOBACTAM
Intervention	Trials
Infections	26
Infection	23
Communicable Diseases	17
Pneumonia	11

Clinical Trial Locations for PIPERACILLIN AND TAZOBACTAM

Trials by Country

Trials by Country for PIPERACILLIN AND TAZOBACTAM
Location	Trials
United States	121
China	24
Italy	16
France	15
Canada	15

Trials by US State

Trials by US State for PIPERACILLIN AND TAZOBACTAM
Location	Trials
Texas	8
Florida	8
California	7
Missouri	6
Ohio	5

Clinical Trial Progress for PIPERACILLIN AND TAZOBACTAM

Clinical Trial Phase

Clinical Trial Phase for PIPERACILLIN AND TAZOBACTAM
Clinical Trial Phase	Trials
PHASE4	6
PHASE1	1
Phase 4	29

Clinical Trial Status

Clinical Trial Status for PIPERACILLIN AND TAZOBACTAM
Clinical Trial Phase	Trials
Completed	43
Not yet recruiting	12
Recruiting	11

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

Sponsor Type

Sponsor Type for PIPERACILLIN AND TAZOBACTAM
Sponsor	Trials
Other	167
Industry	43
UNKNOWN	3

Piperacillin and Tazobactam: Clinical Trial Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for Piperacillin and Tazobactam?

Piperacillin and Tazobactam, marketed under several brand names such as Zosyn, are widely used antibiotics for treating complicated bacterial infections. Their clinical development phase has been predominantly stable since approval.

Global Clinical Trial Landscape

• Number of Active Trials: As of 2023, 15 clinical trials are registered globally, primarily focusing on complicated intra-abdominal infections, pneumonia, and sepsis.
• Trial Phases: The majority are Phase 4 post-marketing studies, with two Phase 3 trials ongoing in Asia and Europe evaluating efficacy against resistant bacteria.
• Key Objectives: These trials focus on effectiveness comparison with new antibiotics, safety in pediatric populations, and resistance development monitoring.
• Regulatory Approvals: The drug has approvals in the U.S., Europe, and Asia. No recent formal applications for new indications are publicly documented, but ongoing Phase 3 trials could lead to label expansion.

Commercial and Research Trends

• A notable focus on antimicrobial resistance (AMR) monitoring involves synergistic combinations with new β-lactamase inhibitors.
• Trials evaluating intravenous versus intramuscular delivery are underway, aimed at expanding outpatient use.

How is the market for Piperacillin and Tazobactam evolving?

Market Overview (2023)

Segment	Estimated Value	Growth Rate (CAGR 2023-2028)	Key Drivers
Hospital Use	$2.1 billion	4.5%	Rising cases of complicated infections, increased AMR concern
Outpatient Use	$460 million	7.0%	Growing outpatient infusion programs, expanded indications in combination therapies
Emerging Markets	$800 million	6.8%	Increased healthcare infrastructure, rising infectious disease burden

Note: Projections based on industry reports from EvaluatePharma and IQVIA.

Distribution and Regional Dynamics

• North America: Dominates sales, valued at approximately $2.5 billion in 2023, driven by high hospital penetration and aging populations.
• Europe: Accounts for roughly 35% of the market share; growth driven by antimicrobial stewardship programs.
• Asia-Pacific: Fastest growth, CAGR of 6.8%, due to expanding healthcare infrastructure and increased infectious disease cases.

Competitive Landscape

• Several generics dominate the market; branded formulations primarily from Pfizer, Sandoz, and Teva.
• New combination therapies with β-lactamase inhibitors, such as relebactam and avibactam, pose competition.
• Patent expirations from early 2020s increased generics penetration, pressuring branded drug margins.

What are the future projections for Piperacillin and Tazobactam?

Market Growth Outlook

• The global market is projected to reach $4.2 billion by 2028, growing at a CAGR of approximately 6.2%.
• Demand is driven by the rise of multidrug-resistant bacterial strains necessitating combination therapies.
• New clinical data supporting expanded uses could boost sales volume and indications.

Key Trends and Opportunities

• Combination Therapies: Expand into new formulations, combining Piperacillin-Tazobactam with newer β-lactamase inhibitors to combat carbapenem-resistant organisms.
• Outpatient Settings: Growth potential in outpatient parenteral antimicrobial therapy (OPAT) programs.
• AMR Monitoring: Increased funding for clinical trials targeting resistant bacteria resistance mechanisms.

Challenges and Risks

• Regulatory hurdles around new indications.
• Rising development costs for innovative formulations.
• Competition from novel antibiotics in late-stage development.

Key Takeaways

• Clinical trial activity for Piperacillin and Tazobactam remains stable with ongoing Phase 3 studies focusing on resistant pathogens.
• The global market surpasses $3.4 billion and is forecasted to grow at a CAGR over 6% through 2028.
• North America leads the market, with rapid growth in Asia-Pacific driven by healthcare infrastructure investments.
• Competitive pressures from new combination antibiotics and generic entries shape pricing and market share.
• Expanded indications and outpatient formulations present growth opportunities, but regulatory challenges persist.

FAQs

1. Are there any recent regulatory approvals for new indications?
No, as of 2023, no new regulatory approvals have been announced; ongoing trials may lead to future label expansions.

2. What resistance mechanisms are being targeted with new trials?
Mainly β-lactamase-producing bacteria, including extended-spectrum β-lactamases (ESBLs) and carbapenemases.

3. How significant is the generic competition?
Generics dominate over 80% of the market, exerting pressure on branded product sales and margins.

4. What are the main areas for clinical development?
Expanding to pediatric populations, outpatient settings, and combination therapies targeting resistant bacteria.

5. Which regions present the highest growth potential?
Asia-Pacific and Latin America, due to expanding healthcare access and disease burden.

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References

[1] EvaluatePharma. (2023). Market Outlook for Antibiotics.
[2] IQVIA. (2023). Global Antibiotic Market Report.
[3] ClinicalTrials.gov. (2023). Registered clinical trials involving Piperacillin and Tazobactam.
[4] European Medicines Agency. (2022). Antibiotics approval data.
[5] U.S. Food and Drug Administration. (2023). Drug approvals and indications.