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
Urinary Tract Infections	2
Respiratory Tract Infections	2
All Cause Mortality	1
Atrial Fibrillation	1

Condition MeSH

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

Cefotaxime Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Cefotaxime Sodium

Cefotaxime sodium is a broad-spectrum cephalosporin antibiotic used to treat a variety of bacterial infections, including lower respiratory infections, septicemia, and infections of the genitourinary tract, skin, and central nervous system. Here, we will delve into the clinical trials, market analysis, and projections for this essential antibiotic.

Clinical Trials and Efficacy

Efficacy in Lower Respiratory Infections

Clinical trials have demonstrated the efficacy of cefotaxime sodium in treating lower respiratory infections. A multicenter study involving 656 patients showed that cefotaxime achieved bacteriologic and clinical cure rates of 89.9% and 93.9%, respectively. When compared to cefazolin in two comparative trials, cefotaxime exhibited superior or equivalent cure rates in all instances[1].

Tolerability and Pharmacokinetics

A study conducted in Chinese healthy subjects evaluated the tolerability, safety, pharmacokinetics, and drug interaction of cefotaxime sodium–tazobactam sodium injection. The results indicated that the combination was well-tolerated at doses ranging from 0.47 to 4.68 g, with linear pharmacokinetics over a dose range of 1.17–3.51 g. There was no significant accumulation after multiple doses, and the pharmacokinetics were not affected by co-administration[3].

Market Analysis

Current Market Size and Growth

The cefotaxime sodium injection market was valued at USD 1.8 billion in 2023 and is projected to reach USD 2.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.2% from 2024 to 2031. This growth is driven by the increasing incidence of bacterial infections, hospital admissions, and the need for effective antibiotics to combat antibiotic resistance[2].

Market Segmentation

The market is segmented based on application (bacterial infections, sepsis, respiratory infections, urinary tract infections, skin infections), product type (cefotaxime sodium injection for intravenous and intramuscular use, cefotaxime sodium powder), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The broad-spectrum antibacterial qualities of cefotaxime sodium and its effectiveness in treating serious infections are key factors driving market expansion[2].

Key Players and Market Trends

The market report includes profiles of prominent companies such as Pfizer, Merck, GlaxoSmithKline, Novartis, Roche, Sanofi, AstraZeneca, Johnson & Johnson, Teva, and Mylan. The increasing use of cefotaxime sodium in various medical contexts, improvements in healthcare infrastructure, and efforts to combat antibiotic resistance are significant trends influencing the market[2].

Projections and Future Outlook

Market Growth Drivers

The demand for cefotaxime sodium is expected to continue growing due to several factors:

• Increasing Incidence of Bacterial Infections: The rise in bacterial illnesses and hospital admissions fuels the need for efficient antibiotics.
• Improvements in Healthcare Infrastructure: Enhanced medical technology and infrastructure make cefotaxime sodium more accessible and easier to use.
• Combatting Antibiotic Resistance: Ongoing efforts to prevent antibiotic resistance drive the development and deployment of strong antibiotics like cefotaxime sodium[2].

Geographical Market Trends

The Asia-Pacific region is anticipated to be a significant growth area due to its large population, increasing healthcare expenditure, and rising incidence of bacterial infections. North America and Europe also remain key markets, driven by advanced healthcare systems and high demand for effective antibiotics[2].

Dosage and Administration

Adult Dosage

Cefotaxime sodium is administered in various dosages depending on the severity of the infection:

• Uncomplicated Infections: 1g every 12 hours.
• Moderate-to-Severe Infections: 1–2g every 8 hours.
• Life-Threatening Infections: 2g IV every 4 hours.
• Surgical Prophylaxis: 1g as a single dose 30–90 minutes before surgery[4].

Pediatric Dosage

For children, the dosage is adjusted based on age and weight:

• Neonates up to 1 week of age: 50mg/kg IV every 12 hours.
• 1–4 weeks of age: 50mg/kg IV every 8 hours.
• Over 1 month of age: 50–180mg/kg in 4–6 equally divided doses[4].

Safety and Tolerability

Adverse Reactions

Common adverse reactions include injection site reactions, colitis, diarrhea, nausea, vomiting, and hypersensitivity reactions. Rare but serious adverse reactions can include blood dyscrasias and elevated liver enzymes[4].

Warnings and Precautions

Cefotaxime sodium should be used with caution in patients with penicillin or other cephalosporin allergies, renal impairment, and gastrointestinal diseases. It is also important to monitor blood counts during prolonged treatments and avoid extravasation[4].

Key Takeaways

• Clinical Efficacy: Cefotaxime sodium has shown high efficacy in treating various bacterial infections, including lower respiratory infections.
• Market Growth: The market is projected to grow from USD 1.8 billion in 2023 to USD 2.5 billion by 2031, driven by increasing bacterial infections and hospital admissions.
• Dosage and Administration: The drug is administered in different dosages based on the severity of the infection and patient age.
• Safety and Tolerability: While generally well-tolerated, cefotaxime sodium can cause adverse reactions and requires caution in certain patient groups.

FAQs

What are the common indications for cefotaxime sodium?

Cefotaxime sodium is indicated for treating susceptible bacteremia, septicemia, lower respiratory and genitourinary tract infections, skin and skin structure infections, bone and joint infections, gynecologic infections, CNS infections, and for surgical prophylaxis[4].

What is the typical dosage for adult patients?

For uncomplicated infections, the typical dosage is 1g every 12 hours. For moderate-to-severe infections, it is 1–2g every 8 hours, and for life-threatening infections, it is 2g IV every 4 hours[4].

What are the potential adverse reactions to cefotaxime sodium?

Common adverse reactions include injection site reactions, colitis, diarrhea, nausea, vomiting, and hypersensitivity reactions. Rare but serious reactions can include blood dyscrasias and elevated liver enzymes[4].

How does the market for cefotaxime sodium injection project to grow?

The market is expected to grow from USD 1.8 billion in 2023 to USD 2.5 billion by 2031, at a CAGR of 4.2% from 2024 to 2031, driven by the increasing incidence of bacterial infections and improvements in healthcare infrastructure[2].

What are the key factors driving the growth of the cefotaxime sodium market?

Key factors include the growing need for efficient antibiotics due to rising bacterial illnesses, improvements in healthcare infrastructure, and ongoing efforts to combat antibiotic resistance[2].

Can cefotaxime sodium be used in pediatric patients?

Yes, cefotaxime sodium can be used in pediatric patients, with dosages adjusted based on age and weight. For neonates up to 1 week of age, the dosage is 50mg/kg IV every 12 hours, and for older children, it is 50–180mg/kg in 4–6 equally divided doses[4].

Sources

1. Clinical trials of cefotaxime for the treatment of bacterial infections of lower respiratory tract. PubMed.
2. Cefotaxime Sodium Injection Market Size and Projections. Market Research Intellect.
3. Tolerability, Safety, Pharmacokinetics and Drug Interaction of Cefotaxime Sodium–Tazobactam Sodium Injection (6:1). Frontiers in Pharmacology.
4. Cefotaxime Prescription & Dosage Information. eMPR.com.