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.
NCT01551394 ↗	Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis	Completed	PENTA Foundation	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
Fayoum University Hospital	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for Cefotaxime Sodium
Sponsor	Trials
Other	8
Industry	3

Clinical Trials Update and Market Outlook for Cefotaxime Sodium

Last updated: April 25, 2026

Cefotaxime sodium is a mature, off-patent injectable cephalosporin used for bacterial infections. Public clinical activity is sparse and fragmented, and the commercial market is dominated by generics, driving price compression and limited differentiation. This profile supports a “low R&D optionality, high formulation and supply-chain sensitivity” thesis rather than a late-stage innovation strategy.

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What is cefotaxime sodium’s clinical and regulatory status?

Cefotaxime is a third-generation cephalosporin administered by injection (commonly IV/IM). In practice, cefotaxime sodium sits in broad-spectrum antibacterial treatment pathways for hospital and acute-care settings.

Evidence base and endpoints (what typically appears in new studies)

Modern cefotaxime publications in major databases usually fall into three buckets:

1. Therapeutic drug monitoring / pharmacokinetics (PK) and dose-exposure relationships in specific populations (renal impairment, pediatrics, pregnancy, ICU).
2. Microbiology and susceptibility surveillance (local resistance patterns; method validation studies).
3. Formulation, bioequivalence, and administration studies rather than large efficacy trials, consistent with off-patent status and generic competition.

Because the product is widely available and generics dominate, the most frequent “clinical trial” activity tends to be smaller PK/BA studies or observational cohorts rather than phase 2-3 confirmatory programs.

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What does the current clinical trials pipeline look like?

No single, consolidated global pipeline snapshot can be produced from the information provided. A reliable update requires live query results from registries (for example, ClinicalTrials.gov, EU CTR, ISRCTN), including: study status, design, indication, and recruitment dates. Under the constraints here, a complete and accurate trial-level update cannot be produced.

Accordingly, no trial counts, phase distribution, or site-level enrollment metrics are included.

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How is the market structured for cefotaxime sodium?

Commercial model: generics dominate

Cefotaxime sodium has long-standing global manufacturing and a large installed base of generic products. Market outcomes typically depend on:

• Tender pricing in hospitals and government procurement
• Supply stability (active pharmaceutical ingredient availability, sterile manufacturing capacity)
• Regulatory compliance for injectable products (quality systems, batch release turnaround)
• Form factor and concentration options (vial sizes, reconstitution guidance, product labeling)

Indication scope (demand drivers)

Demand is tied to broad “injection antibiotic” usage patterns, including:

• Empiric therapy for suspected bacterial infections in acute care
• Treatment settings where cefotaxime is on institutional formularies or antibiotic pathways
• Pediatric and adult hospital use where local guidance supports third-generation cephalosporins

Resistance and stewardship impact

Third-generation cephalosporins face competitive substitution pressures from newer beta-lactam/beta-lactamase inhibitor combinations and cephalosporin-lower alternatives when stewardship programs tighten use. The result is typically:

• Slower growth than antibiotic spend overall
• More reliance on procurement contracts
• Greater volatility by country and hospital formulary cycles

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What are the market sizing and forecast assumptions?

A defensible market projection needs at least one verifiable anchor (current global sales, leading geography revenues, average selling price, or procurement volume). That information is not provided in the prompt, so a complete and accurate numeric forecast cannot be produced here.

The practical projection framework for a mature generic injectable like cefotaxime sodium is:

Forecast mechanics (used by buyers and financial models)

• Volume: tied to hospital admissions, empiric antibiotic protocols, and tender award continuity
• Price: tied to generic competition, API spreads, and regulatory lot supply constraints
• Mix: concentration, pack size, and product availability by region
• Substitution: stewardship-driven preference for alternatives in ICU and severe infection pathways

Given these dynamics, baseline outcomes in mature antibiotics are typically “flat-to-slow decline in value with stable-to-slightly growing volume,” but that cannot be translated into numbers without source anchors.

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Where does value pool exist in cefotaxime sodium?

With limited patent-led differentiation, value creation tends to concentrate in operational advantages:

High-impact value levers

• Sterile manufacturing yield and batch release reliability (reduces tender failures and stockouts)
• Portfolio breadth: offering multiple vial sizes and strengths to meet hospital formulary variants
• Regulatory throughput: fast approvals and dossier maintenance in high-volume geographies
• Tender responsiveness: pricing discipline tied to API sourcing and conversion cost control

Low-impact differentiation

• Small-labeling variations
• Minor formulation changes that do not change procurement eligibility
• Clinical “innovation claims” that do not alter outcomes versus existing generics

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Competitive landscape: who matters?

For cefotaxime sodium, competition typically includes:

• Global and regional generic manufacturers with injectable portfolios
• Local sterile injectables players that win tenders by supply continuity and price

A full competitive map requires issuer-specific sales, approval statuses, and tender performance, none of which is present in the prompt.

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What investment or R&D strategy fits cefotaxime sodium?

Given typical generics economics, the most actionable R&D targets are not new phase 3 efficacy studies. Practical pathways usually include:

Commercially rational R&D directions

• Formulation and presentation optimization aimed at procurement convenience
• Bioequivalence and regulatory extensions in priority markets
• Supply-chain resiliency (sterile site redundancy, API sourcing diversification)
• Quality system upgrades that reduce batch rejection risk

Non-rational directions for a generic label (in most cases)

• Large randomized efficacy programs without a clear differentiation hypothesis
• New mechanism-of-action claims without patent or substantial clinical differentiation

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Key takeaways

• Cefotaxime sodium is a mature, off-patent injectable cephalosporin where demand is driven by hospital procurement and institutional antibiotic pathways.
• Clinical “trial” activity is likely skewed toward PK, bioequivalence, and observational or microbiology studies, but a complete current pipeline update cannot be produced without registry-level inputs.
• Market outcomes are dominated by generics competition, tender pricing, and supply stability; differentiation through new efficacy trials is typically low ROI.
• A numeric market projection is not supportable from the provided information because market sizing anchors (sales, volumes, ASP) are not supplied.

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FAQs

1. Is cefotaxime sodium still used clinically in acute care?
   Yes. It is routinely used as an injectable third-generation cephalosporin in hospital settings where formularies and local guidance support its role.

2. What types of studies dominate for cefotaxime sodium today?
   Typically PK, bioequivalence, stability/administration, and susceptibility surveillance rather than large new efficacy phase 2-3 programs.

3. How does antibiotic stewardship affect cefotaxime sodium demand?
   It can reduce use in favor of narrower or more targeted alternatives, creating pressure on value even if volume remains stable.

4. What determines pricing for cefotaxime sodium in most countries?
   Generic competition and tender awards, with additional sensitivity to sterile manufacturing capacity and API availability.

5. Where can companies still create advantage with cefotaxime sodium?
   In operational excellence: reliable supply, batch release performance, regulatory throughput, and matching tender pack formats to procurement requirements.

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References

[1] ClinicalTrials.gov. (n.d.). Cefotaxime sodium search results. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and labels for cefotaxime (search portal). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. (n.d.). Public assessment reports and product information for cefotaxime (search portal). https://www.ema.europa.eu/