CLINICAL TRIALS PROFILE FOR CEFOTAXIME

All Clinical Trials for CEFOTAXIME

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124228 ↗	Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis	Completed	Fondo de Investigacion Sanitaria	Phase 3	2004-11-01	Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p
NCT00124228 ↗	Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis	Completed	Hospital Clinic of Barcelona	Phase 3	2004-11-01	Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	IL Sogno di Stefano	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	Regione Veneto	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	University of Padova	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
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.

Clinical Trial Conditions for CEFOTAXIME

Condition Name

Condition Name for CEFOTAXIME
Intervention	Trials
Spontaneous Bacterial Peritonitis	4
Urinary Tract Infections	4
Respiratory Tract Infections	3
Sepsis	3

Condition MeSH

Condition MeSH for CEFOTAXIME
Intervention	Trials
Infections	9
Peritonitis	8
Infection	8
Communicable Diseases	6

Clinical Trial Locations for CEFOTAXIME

Trials by Country

Trials by Country for CEFOTAXIME
Location	Trials
Egypt	8
Spain	6
France	4
Sweden	3
Vietnam	2

Trials by US State

Trials by US State for CEFOTAXIME
Location	Trials
Virginia	1

Clinical Trial Progress for CEFOTAXIME

Clinical Trial Phase

Clinical Trial Phase for CEFOTAXIME
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	14
Phase 3	7

Clinical Trial Status

Clinical Trial Status for CEFOTAXIME
Clinical Trial Phase	Trials
Completed	20
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for CEFOTAXIME

Sponsor Name

Sponsor Name for CEFOTAXIME
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
Tanta University	2
Xiangbei Welman Pharmaceutical Co., Ltd	2

Sponsor Type

Sponsor Type for CEFOTAXIME
Sponsor	Trials
Other	54
Industry	3
OTHER_GOV	1

CEFOTAXIME Market Analysis and Financial Projection

Last updated: April 28, 2026

Clinical Trials Update, Market Analysis, and Projections for Cefotaxime

Cefotaxime is an established parenteral third-generation cephalosporin with a long commercial footprint, extensive clinical use in hospital and institutional settings, and a mature patent landscape in most markets. Clinical development activity is typically incremental (new formulations, new indications in narrower populations, and trial updates for stewardship-era endpoints), while commercial growth is driven by antimicrobial guideline adherence, hospital utilization, and competitive pricing across generic manufacturers.

What is the current clinical trial landscape for cefotaxime?

No recent, global phase-1 to phase-3 “breakthrough” cefotaxime development programs dominate public registries; most new activity is small-scale or formulation/PK-focused and is often paired with comparative or non-inferiority design. In practice, cefotaxime clinical updates track:

• Optimization trials: dosing strategy, administration schedule, and therapeutic drug monitoring concepts where applicable to β-lactams.
• Stewardship-era outcomes: clinical cure or microbiological eradication endpoints aligned to newer guidance (hospital-acquired and community-acquired infection frameworks).
• Formulation and access studies: stability, reconstitution, and bioequivalence for generic/authorized products rather than brand-new molecular entities.

A practical way to monitor “what is actively changing” for cefotaxime is to separate (1) new molecular trials from (2) ongoing institutional registries and (3) formulation studies tied to regulatory submissions. This matters for market projections because generic supply does not require large, high-capex phase-3 programs to sustain revenue.

Clinical development signaling

• High likelihood of incremental trials rather than new registrational phase programs.
• Short-cycle studies (pharmacokinetics, stability, or formulation) are more common than large efficacy trials.

Where does cefotaxime generate demand today?

Cefotaxime demand concentrates in inpatient and institutional use for bacterial infections where clinicians prefer a third-generation cephalosporin option and where local formularies support it.

Primary use-cases

• Serious bacterial infections treated in hospital settings, including severe community-acquired and hospital-acquired infections depending on local resistance patterns.
• Sepsis and bloodstream infection pathways where clinicians select β-lactams based on organism susceptibility and resistance epidemiology.
• Gynecology, intra-abdominal, and surgical prophylaxis-adjacent regimens in certain protocols (varies by country and guideline).

Key demand drivers

• Antimicrobial stewardship and guideline adherence: cefotaxime is used when susceptibility and local antibiograms support third-generation cephalosporins.
• Resistance dynamics: increased resistance to Enterobacterales and shifts toward carbapenem-sparing strategies can either support or restrict use depending on ESBL prevalence.
• Hospital purchasing behavior: tenders and price competition across generics dominate.

How big is the cefotaxime market and what is the revenue structure?

The cefotaxime market is mature and supply-led, with revenue dominated by generic products and regional tender markets. Brand-led pricing is limited because most jurisdictions have moved to generic competition.

Because cefotaxime is an older antibiotic with broad generic availability, the addressable market is best modeled through: 1) Hospital penetration (share of facilities stocking cefotaxime)
2) Line-item usage rates (doses per 100 admissions or per infection-treated case)
3) Tender pricing and mix (strength, pack size, and route)
4) Regulatory channel (local registrations, supply constraints, and distribution maturity)

Market structure

• Product type: injectable cephalosporin, primarily hospital-administered.
• Competitive set: other third-generation cephalosporins and broad-spectrum β-lactams, with frequent substitution based on resistance and formulary access.

What do resistance and stewardship trends do to cefotaxime sales?

Cefotaxime use is tightly coupled to susceptibility patterns and hospital antimicrobial protocols.

Impact pathways

• ESBL and AmpC prevalence: higher prevalence reduces empirical suitability for third-generation cephalosporins in some geographies, shifting utilization toward alternatives.
• De-escalation practice: when cultures confirm susceptibility, cefotaxime can capture therapy step-down from broader agents.
• Infection control: stewardship programs can restrict “default” third-generation cephalosporin use, but they also create demand for targeted, narrow-spectrum therapy when possible.

Net effect on demand

• Expect regionally volatile utilization: markets with higher ESBL rates may see slower volume growth or periodic declines, while others remain stable.
• Revenue is generally price elastic due to generic tendering.

How should investors project cefotaxime market growth?

A credible projection framework for cefotaxime is not built on brand innovation; it is built on utilization stability and tender economics.

Projection model (scenario-based)

Use a three-variable model:

Volume driver

• Admissions treated with cefotaxime based on formulary status and resistance-adjusted prescribing.

Price driver

• Weighted average selling price (WASP) driven by tender pricing and manufacturer supply.

Mix driver

• Dose intensity and pack configuration (strengths and dosing frequency) which can change with guideline uptake and local protocols.

Three scenarios

• Base case (steady-state): modest volume stability with declining or flat pricing typical for mature injectables.
• Bull case (stewardship-driven de-escalation): culture-guided de-escalation supports use after broad-spectrum initiation; tender competition stays moderate.
• Bear case (resistance pressure and substitution): higher ESBL rates or formulary shifts reduce empirical selection and weaken de-escalation capture; price erosion accelerates.

Indicative annual dynamics (how to think about directionality)

• Volume: tends to be stable to slightly down/up depending on local antibiogram trends and guideline compliance intensity.
• Price: generally downward in generic tenders, unless supply tightness or regulatory constraints raise short-term pricing.
• Revenue: tracks volume more than price over long horizons, because price erosion can offset small volume gains.

What is the patent and competitive outlook?

Cefotaxime is an old molecule, and the market is characterized by:

• Extensive generic entry in major jurisdictions.
• Limited patent-driven exclusivity for new market entrants.
• Competition from other cephalosporins and β-lactams depending on local susceptibility and guideline recommendations.

Commercial implication

• Market shares rotate among generic suppliers based on supply reliability, regulatory listings, and tender contracts rather than patent-led innovation.

What are the regulatory and guideline references that affect use?

Cefotaxime prescribing is guided by:

• National formularies and hospital protocols aligned to third-generation cephalosporin use.
• Antimicrobial stewardship standards and local antibiograms.

While specific label language varies by jurisdiction, the clinical use-case remains consistent: serious bacterial infections where organism susceptibility supports cephalosporin therapy.

How should companies evaluate cefotaxime R&D opportunities (if any)?

For cefotaxime, “R&D” usually means practical product or clinical positioning rather than new chemical entity development.

Most plausible commercial R&D lanes

• Formulation and stability improvements for reconstitution, storage, and shelf-life optimization.
• Comparative PK and equivalence work to support regulatory submissions efficiently.
• Targeted clinical studies that strengthen guideline placement in defined infection subsets or populations where third-generation cephalosporins remain active.

What tends to create measurable market impact

• Faster time-to-availability in procurement cycles
• Reduced supply disruption
• Demonstrated stability and handling improvements that hospitals can operationalize

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Key Takeaways

• Cefotaxime’s clinical footprint is mature; public “major registrational” trials are limited and most new activity is incremental (formulation and PK/equivalence work rather than new efficacy platforms).
• Demand is driven by hospital/institution utilization and antimicrobial stewardship implementation, with utilization constrained or expanded by local resistance patterns, especially ESBL prevalence.
• Market growth is best projected through tender economics and utilization stability; price typically trends down in generic-heavy procurement environments.
• Competitive dynamics center on generic supplier readiness and contract access rather than patent-led innovation.
• R&D that moves the needle is likely formulation, stability, and targeted evidence to support placement in local protocols.

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FAQs

1) Is cefotaxime still actively used in hospitals?
Yes. Cefotaxime remains a common injectable third-generation cephalosporin in inpatient formularies, where its use depends on susceptibility and guideline placement.

2) What determines whether cefotaxime demand grows or declines in a given region?
Local resistance patterns, especially ESBL and AmpC trends, plus hospital prescribing guidelines and de-escalation practices.

3) Does cefotaxime have meaningful patent protection driving premium pricing?
No. The molecule is established with extensive generic competition across major markets, so pricing and share are tender-driven.

4) What types of new trials are most likely for cefotaxime today?
Formulation-related studies and pharmacokinetic or equivalence studies, plus smaller clinical studies aligned with current endpoint frameworks.

5) How should investors set assumptions for cefotaxime market projections?
Model volume based on formulary utilization and de-escalation capture, and model revenue with tender-based pricing erosion and mix effects rather than assuming premium pricing growth.

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References

1. European Centre for Disease Prevention and Control (ECDC). Antimicrobial resistance surveillance and antimicrobial use reports.
2. WHO. Global action on antibiotic resistance and stewardship guidance.
3. FDA. Guidance documents and labeling framework for antibacterial drugs and clinical trial endpoints.