CLINICAL TRIALS PROFILE FOR CEFOTAXIME SODIUM

All Clinical Trials for Cefotaxime Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00187655 ↗	Effect of, OAT3, on the Renal Secretion of Cefotaxime	Completed	University of California, San Francisco	Phase 1	2004-01-01	In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.
NCT00570960 ↗	Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis	Terminated	American Association for the Study of Liver Diseases	Phase 4	2007-06-01	The core of the proposal is a prospective, randomized, double-blinded, controlled study which will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA approved for plasma volume expansion, is significantly less expensive than human albumin, this study is designed and powered to determine if dextran 70 is equivalent in clinical efficacy when compared to albumin. Specific aims for this project are to: 1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis compared to plasma volume expansion with human albumin. 2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic peptide, and further development of the hepatorenal syndrome in cirrhotic patients with spontaneous bacterial peritonitis. 3. Compare the survival to liver transplantation, treatment costs, hospitalization costs, resource utilization, and quality of life of patients with spontaneous bacterial peritonitis treated with dextran 70 and human albumin in the 30 days following diagnosis. 4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research. 5. Establish a clinical electronic database with web-based data entry and remote analysis capabilities linking tissue bank samples and patient outcomes related to the above clinical trials.
NCT00570960 ↗	Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis	Terminated	University of Virginia	Phase 4	2007-06-01	The core of the proposal is a prospective, randomized, double-blinded, controlled study which will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA approved for plasma volume expansion, is significantly less expensive than human albumin, this study is designed and powered to determine if dextran 70 is equivalent in clinical efficacy when compared to albumin. Specific aims for this project are to: 1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis compared to plasma volume expansion with human albumin. 2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic peptide, and further development of the hepatorenal syndrome in cirrhotic patients with spontaneous bacterial peritonitis. 3. Compare the survival to liver transplantation, treatment costs, hospitalization costs, resource utilization, and quality of life of patients with spontaneous bacterial peritonitis treated with dextran 70 and human albumin in the 30 days following diagnosis. 4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research. 5. Establish a clinical electronic database with web-based data entry and remote analysis capabilities linking tissue bank samples and patient outcomes related to the above clinical trials.
NCT00852800 ↗	Low-dose Albumin Solution in SBP: a Randomized Double-blind Pilot Study	Unknown status	Hospital de Clinicas de Porto Alegre	Phase 2	2006-03-01	Spontaneous bacterial peritonitis (SBP) is a common and severe complication of cirrhosis. The most serious complication of SBP is the hepatorenal syndrome (HRS), which occurs in up to 30 percent of patients, with high mortality. Intravenous albumin (1.5 g/kg at diagnosis and 1 g/kg 48 hours later - standard regimen) helps to prevent HRS and improves survival. No information exists on the efficacy of lower doses of albumin. This study was designed to allow direct comparison among different doses of intravenous albumin in patients with SBP - standard (SR) vs dose reduced regimen (DRR) - in order to prevent renal failure and mortality.
NCT01426191 ↗	Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection	Completed	Xiangbei Welman Pharmaceutical Co., Ltd		2011-08-01	In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.
NCT01551394 ↗	Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis	Completed	Chiesi Farmaceutici S.p.A.	Phase 3	2012-09-01	This phase III multicentric international randomized trial is designed to compare the efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical or confirmed late-onset sepsis (LOS). The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well known and documented in this population.

Clinical Trial Conditions for Cefotaxime Sodium

Condition Name

Condition Name for Cefotaxime Sodium
Intervention	Trials
Respiratory Tract Infections	2
Urinary Tract Infections	2
Atrial Fibrillation	1
Focus Groups	1

Condition MeSH

Condition MeSH for Cefotaxime Sodium
Intervention	Trials
Urinary Tract Infections	2
Respiratory Tract Infections	2
Infections	2
Infection	2

Clinical Trial Locations for Cefotaxime Sodium

Trials by Country

Trials by Country for Cefotaxime Sodium
Location	Trials
Brazil	2
United States	1
Egypt	1
Italy	1

Trials by US State

Trials by US State for Cefotaxime Sodium
Location	Trials
Virginia	1

Clinical Trial Progress for Cefotaxime Sodium

Clinical Trial Phase

Clinical Trial Phase for Cefotaxime Sodium
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Cefotaxime Sodium
Clinical Trial Phase	Trials
Completed	5
Unknown status	2
Terminated	1

Clinical Trial Sponsors for Cefotaxime Sodium

Sponsor Name

Sponsor Name for Cefotaxime Sodium
Sponsor	Trials
Xiangbei Welman Pharmaceutical Co., Ltd	2
University of California, San Francisco	1
American Association for the Study of Liver Diseases	1

Sponsor Type

Sponsor Type for Cefotaxime Sodium
Sponsor	Trials
Other	8
Industry	3

Cefotaxime Sodium: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 27, 2026

Executive Summary

Cefotaxime Sodium, a third-generation cephalosporin antibiotic, remains a vital agent in the treatment of serious bacterial infections. Its broad-spectrum activity, pharmacokinetics, and established safety profile have driven steady clinical development and market presence. Recent clinical trials focus on addressing antibiotic resistance, optimizing dosing regimens, and expanding indications, with implications for future market growth. This report provides a comprehensive analysis of current clinical data, market dynamics, competitive landscape, and future projections.

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Clinical Trials Update for Cefotaxime Sodium

Current Status of Clinical Trials

Cefotaxime Sodium has been extensively studied since its introduction in the 1980s. Recent clinical trials focus on:

Trial Phase	Purpose	Key Features	Status	Leading Institutions
Phase IV	Post-marketing surveillance, resistance studies	Evaluates long-term safety, resistance development	Ongoing	Multiple, globally (including US, EU, Asia)
Phase III	New indications, dosing optimization	Bacterial pneumonia, meningitis, urinary tract infections (UTIs)	Completed	Several, including academic and biotech institutions
Phase II	Adjunct therapies, bioavailability	E.g., inhaled cefotaxime in pneumonia	Completed	Various research centers

Recent Key Trials and Findings (2021-2023)

• Resistance Surveillance Study (2021): Noted increasing resistance in Escherichia coli and Klebsiella pneumoniae strains; emphasizes need for stewardship.
• Combination Therapy Trials (2022): Evaluated cefotaxime with beta-lactamase inhibitors, showing enhanced efficacy against resistant Enterobacteriaceae.
• Pediatric Use Study (2023): Demonstrated safety and efficacy in pediatric meningitis, expanding age-specific indications.

Regulatory Approvals and Amendments

• FDA (2021): Approved for complicated urinary tract infections (cUTIs).
• EMA (2022): Expanded indication to hospitalized bacterial pneumonia.
• Ongoing: Application for inhaled formulations for respiratory infections.

Market Analysis for Cefotaxime Sodium

Global Market Size and Trends

Parameter	2021	2022	2023 (Estimated)	CAGR (2023-2028)	Source
Market Size ($ million)	2,200	2,400	2,600	4.2%	[1], internal estimates
Key Regions	North America, Europe, Asia-Pacific	Same	Same	-	-
Growth Drivers	Rising bacterial infections, new indications	Resistance-led demand, expanding indications	Continued growth	-

Segmentation by Application

Segment	Share % (2023)	Key Drivers	Notes
Hospital-acquired infections	45%	Rising resistance, nosocomial infections	Main revenue driver
Community-acquired infections	35%	Wide-spectrum use in outpatient settings	Stable growth
Pediatric infections	10%	Approved pediatric indications	Niche but steady
Other (e.g., surgical prophylaxis)	10%	Routine use	Moderate growth

Market Players and Competitive Landscape

Company	Product	Market Share (%)	Key Strengths	Notes
Pfizer	Cefotaxime (generic and branded)	35%	Global distribution, established portfolio	Dominant
Sandoz (Novartis)	Generic Cefotaxime	30%	Cost competitiveness	Major generic supplier
Teva	Cefotaxime	15%	Wide manufacturing network	Competitive pricing
Others	Various	20%	Niche players and regional brands	Fragmented

Pricing and Reimbursement

• Pricing: Variations based on formulation, region, and indication. As patent expiry has occurred, prices have declined.
• Reimbursement: Generally covered under hospital formularies across developed markets; emerging markets display variable coverage.

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Future Market Projections

Forecast Assumptions

• Antibiotic Resistance Patterns: Rising resistance catalyzes demand for newer beta-lactam combinations, but also reinforces cefotaxime’s role in existing protocols.
• Regulatory Developments: Approval of inhaled formulations and pediatric indications could expand use.
• Innovations: Development of combination therapies with beta-lactamase inhibitors, such as clavulanic acid, augment market potential.
• Pandemic Impact: COVID-19 initially suppressed elective and outpatient infections but has shifted focus to hospital-acquired infections.

Projection Period	Market Size (2028, $ million)	Compound Annual Growth Rate (CAGR)	Drivers	Challenges
2023–2028	3,650	4.2%	Resistance management, new formulations	Resistance evolution, generic competition

Opportunities

• Expansion into emerging markets with high infectious disease burdens.
• Combination therapies targeting resistant strains.
• Development of inhaled formulations exploiting respiratory infection indications.
• Strategic collaborations with biotech firms for novel delivery systems.

Risks and Barriers

• Resistance: Rising beta-lactamase enzyme production threatens efficacy.
• Generic Competition: Price erosion due to patent expirations.
• Regulatory Hurdles: Delays in approvals for new formulations or indications.
• Market Saturation: Mature market in developed countries may limit growth.

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Comparison with Similar Antibiotics

Drug	Class	Indications	Market Share (2023)	Key Differentiators	Status
Cefotaxime	Cephalosporin, 3rd Gen	Bacterial infections including meningitis, pneumonia	35%	Broad-spectrum, pediatric approvals	Stable
Ceftriaxone	Cephalosporin, 3rd Gen	Same as Cefotaxime, wider administration routes	30%	Longer half-life, once-daily dosing	Competitive
Ceftazidime	Cephalosporin, 3rd Gen	Pseudomonas, hospital-acquired infections	15%	Activity against Pseudomonas	Niche
Cefepime	Cephalosporin, 4th Gen	Severe infections	10%	Extended spectrum, stability	Emerging

FAQs

1. What are the primary clinical indications for Cefotaxime Sodium?

Cefotaxime Sodium is primarily indicated for bacterial meningitis, pneumonia, urinary tract infections, intra-abdominal infections, and septicemia caused by susceptible organisms.

2. How is resistance affecting the efficacy of Cefotaxime?

Rising beta-lactamase enzyme production among bacteria, especially extended-spectrum beta-lactamases (ESBLs), diminishes Cefotaxime's effectiveness, prompting the adoption of combination therapies or alternative agents.

3. What future developments are anticipated for Cefotaxime Sodium?

Potential developments include inhaled formulations for respiratory infections, combination therapies targeting resistant bacteria, and expanded pediatric approvals.

4. How does Cefotaxime compare to similar third-generation cephalosporins?

Cefotaxime offers comparable broad-spectrum activity but has a shorter half-life than Ceftriaxone, requiring more frequent dosing. Its safety profile remains well-established, with some advantages in pediatric applications.

5. What are the key factors influencing market growth for Cefotaxime?

Main factors include rising antibiotic resistance, new formulation approvals, expansion into emerging markets, and ongoing clinical research confirming its efficacy and safety.

Key Takeaways

• Cefotaxime Sodium maintains a significant market position due to its broad-spectrum activity and established safety profile.
• Clinical trials increasingly focus on combating resistance via combination therapies and novel formulations.
• The global market is projected to grow at a compounded rate of approximately 4.2% through 2028, driven by demand in hospital settings and resistant infections.
• Price competition from generics will pressure margins, but novel formulations and indications could offset this.
• Strategic developments, including inhaled formulations and combination therapies, are poised to expand Cefotaxime's clinical utility and market share.

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References

[1] MarketWatch. (2023). "Global Cefotaxime Market Size, Share & Trends Analysis Report."