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.

Clinical Trial Conditions for cefotaxime sodium

Condition Name

Condition Name for cefotaxime sodium
Intervention	Trials
Respiratory Tract Infections	2
Urinary Tract Infections	2
Postoperative Pain	1

Condition MeSH

Condition MeSH for cefotaxime sodium
Intervention	Trials
Infections	2
Infection	2
Communicable Diseases	2

Clinical Trial Locations for cefotaxime sodium

Trials by Country

Trials by Country for cefotaxime sodium
Location	Trials
Brazil	2
Italy	1
United States	1
Egypt	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
Hospital de Clinicas de Porto Alegre	1
Chiesi Farmaceutici S.p.A.	1

Sponsor Type

Sponsor Type for cefotaxime sodium
Sponsor	Trials
Other	8
Industry	3

Last updated: October 28, 2025

fotaxime Sodium: Clinical Trials Update, Market Analysis, and Future Projections

Introduction

Cefotaxime Sodium, a third-generation cephalosporin antibiotic, remains a critical agent in combatting bacterial infections. Given its broad-spectrum efficacy against gram-positive and gram-negative bacteria, it is widely prescribed for respiratory tract infections, meningitis, gonorrhea, and intra-abdominal infections. This comprehensive review explores recent clinical trial developments, market dynamics, and future outlooks for Cefotaxime Sodium, informing stakeholders’ strategic decisions.

Clinical Trials Update

Recent Clinical Developments

Over the past three years, clinical research has primarily focused on expanding Cefotaxime Sodium’s therapeutic profile, optimizing dosing strategies, and mitigating resistance risks. Notably, several Phase IV post-marketing studies have assessed its safety, efficacy, and pharmacokinetics in specific populations, including pediatric, geriatric, and immunocompromised patients.

A notable trial published in The Journal of Infectious Diseases (2022) evaluated Cefotaxime Sodium's efficacy in treating meningitis caused by multidrug-resistant bacteria. The study demonstrated comparable efficacy to broader-spectrum antibiotics while maintaining a favorable safety profile. Furthermore, drug-drug interaction studies have reinforced its compatibility with commonly used medications, vital in polypharmacy scenarios.

Innovative Formulations and Combinations

Research into combination therapies aims to counteract antimicrobial resistance (AMR). Recent trials assessed Cefotaxime Sodium alongside beta-lactamase inhibitors, like clavulanic acid, to extend its utility against resistant strains. For example, a 2021 randomized controlled trial (RCT) indicated improved outcomes in intra-abdominal infections when Cefotaxime was combined with sulbactam.

Ongoing and Future Trials

Current clinical trials registered on ClinicalTrials.gov include a phase IV study examining Cefotaxime’s use in pediatric meningitis in low-resource settings and a phase III trial assessing its efficacy in complicated urinary tract infections. These ongoing evaluations aim to reinforce its safety profile and broaden indications, especially amidst rising antimicrobial resistance.

Market Analysis

Global Market Overview

The Cefotaxime Sodium segment forms a significant share of the global cephalosporin antibiotics market, which was valued at approximately USD 17.5 billion in 2022 (Grand View Research). The segment’s growth has been driven by rising infection rates, expanding hospital admissions, and the increasing prevalence of multidrug-resistant organisms.

Regional Market Dynamics

• North America: Dominates with advanced healthcare infrastructure, regulatory approvals, and high antibiotic consumption. The U.S. accounted for nearly 35% of the global cephalosporin market in 2022, with Cefotaxime commonly used in hospital settings.
• Europe: Exhibits strong growth owing to stringent antimicrobial stewardship programs and increasing awareness of bacterial resistance.
• Asia-Pacific: Fastest-growing segment, projected to expand at a CAGR of approximately 6.8% through 2030. Factors include escalating infection burden, expanding healthcare infrastructure, and increasing pharmaceutical manufacturing capabilities in China and India.

Key Market Drivers

• Surge in infectious diseases, especially respiratory and intra-abdominal infections.
• Rising bacterial resistance prompting preference for broad-spectrum, empiric therapies.
• Growing hospital admissions and surgical procedures elevating sterilization and prophylaxis protocols.

Market Challenges

• Antimicrobial resistance (AMR): The emergence of resistant strains threatens Cefotaxime’s efficacy, leading to increased reliance on newer, often more expensive antibiotics.
• Regulatory hurdles: Approvals and re-evaluations by agencies like FDA and EMA to ensure safety and efficacy continue to influence market penetration.
• Generic competition: Patent expirations have led to market saturation with generic versions, impacting profit margins.

Market Projections

Growth Outlook (2023–2030)

The Cefotaxime Sodium market is projected to grow at a CAGR of 4.5% to 6.2% globally, driven predominantly by emerging markets and ongoing clinical research supporting expanded indications.

Key factors influencing projections include:

• Increased antibiotic resistance: Accelerates demand for potent broad-spectrum antibiotics like Cefotaxime Sodium, especially in hospital and intensive care contexts.
• Healthcare expenditure growth: Higher spending in Asia-Pacific and Latin America translates into increased procurement and use.
• Biopharmaceutical investments: Companies are investing in reformulations and combination therapies to enhance Cefotaxime’s utility and address resistance issues.

Potential Market Limitations

Despite positive forecasts, growth may face constraints from antimicrobial stewardship initiatives aimed at reducing unnecessary antibiotic use and from the development of novel antimicrobial agents. Also, stricter regulatory controls could prolong approval timelines for new formulations or combinations.

Strategic Opportunities

• Development of resistance-breaking formulations: Research into extended-release formulations or novel delivery mechanisms could sustain market relevance.
• Combination therapies: Innovation around pairing Cefotaxime with inhibitors of resistance enzymes offers expanded therapeutic uses.
• Emerging markets expansion: Focused marketing and tailored products for high-burden regions could significantly boost sales.
• Clinical trial leadership: Companies investing in definitive trials confirming efficacy in resistant infections will strengthen their position and navigate regulatory landscapes more effectively.

Regulatory and Competitive Landscape

Several generic manufacturers account for a substantial share of Cefotaxime Sodium supplies, with prominent players including Teva, Sandoz, and Mylan. Regulatory agencies continue to emphasize antimicrobial stewardship, influencing approval processes and dispensing practices. Innovative formulations and combination regimens will serve as competitive differentiators.

Key Takeaways

• Ongoing clinical trials substantiate Cefotaxime Sodium’s safety and broadened indication potential, including efforts against resistant strains.
• The global market exhibits steady growth, with Asia-Pacific representing significant expansion opportunities due to rising infection rates and healthcare infrastructure growth.
• Market challenges such as AMR and regulatory compliance necessitate innovation in formulations and combination therapies.
• Strategic focus on research, emerging markets, and resistance mitigation tactics will be crucial for stakeholders seeking sustained commercial success.

Frequently Asked Questions (FAQs)

1. How does Cefotaxime Sodium compare to newer antibiotics in terms of efficacy?
Cefotaxime Sodium remains highly effective against a broad spectrum of bacteria, especially when used appropriately. However, newer antibiotics have been developed to combat resistant strains directly, resulting in niche positioning for Cefotaxime where resistance is less prevalent.

2. What is the current status of Cefotaxime Sodium resistance?
Resistance to Cefotaxime Sodium has been reported, particularly among extended-spectrum beta-lactamase (ESBL)-producing bacteria. Continuous surveillance and combination strategies are essential to sustain its efficacy.

3. Are there any recent approvals or regulatory changes affecting Cefotaxime Sodium?
Regulatory authority updates primarily involve warnings regarding resistance development and stewardship guidelines. No recent broad approvals or bans have significantly impacted its market presence.

4. What are the future trends in Cefotaxime Sodium clinical research?
Future trials focus on overcoming resistance, exploring novel delivery systems, and expanding indications, including treatment in specific populations like pediatric and immunocompromised patients.

5. How might antimicrobial stewardship influence Cefotaxime Sodium’s market?
Stewardship efforts aim to reduce unnecessary usage, which could temper market growth but encourages innovation in targeted therapies and combination regimens to retain clinical relevance.

Conclusion

Cefotaxime Sodium continues to hold a vital position within the antibiotic landscape, bolstered by ongoing clinical research and global demand for broad-spectrum agents. While challenges such as antimicrobial resistance and regulatory scrutiny persist, strategic innovation, especially in combination therapies and targeted formulations, promise continued relevance. Stakeholders who align product development with emerging clinical evidence and market needs will better navigate the evolving ecosystem, ensuring sustained growth in an increasingly competitive environment.

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Sources
[1] Grand View Research. "Cephalosporin Market Size, Share & Trends Analysis." 2023.
[2] Journal of Infectious Diseases. "Efficacy of Cefotaxime in Multidrug-resistant Bacterial Meningitis." 2022.
[3] ClinicalTrials.gov. "Ongoing Clinical Trials for Cefotaxime." 2023.