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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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
Cirrhosis	3
Respiratory Tract Infections	3

Condition MeSH

Condition MeSH for CEFOTAXIME
Intervention	Trials
Infections	9
Infection	8
Peritonitis	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	2
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	1
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
Fayoum University Hospital	2
Assistance Publique - Hôpitaux de Paris	2
Tanta University	2

Sponsor Type

Sponsor Type for CEFOTAXIME
Sponsor	Trials
Other	53
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Cefotaxime

Last updated: October 25, 2025

Introduction

Cefotaxime, a third-generation cephalosporin antibiotic, has been a cornerstone in the treatment of serious bacterial infections since its approval in the early 1980s. Its broad-spectrum activity against gram-positive and gram-negative bacteria positions it as a vital therapeutic agent in hospital and outpatient settings. The evolving landscape of antimicrobial resistance, regulatory dynamics, and emerging clinical data influence its clinical use, market trajectory, and future potential. This report offers a comprehensive update on recent clinical trials, analyzes the current market landscape, and projects future trends for Cefotaxime.

Clinical Trials Update

Recent Clinical Trial Landscape

In the recent period, the focus of clinical research involving Cefotaxime has primarily shifted towards combating antimicrobial resistance (AMR) and optimizing its use in specific infectious diseases. Notably:

• Combination therapies: Multiple phase IV studies evaluate Cefotaxime in combination with other agents, aiming to enhance efficacy against resistant pathogens. For example, trials assessing Cefotaxime plus β-lactamase inhibitors explore its potential in resistant Enterobacteriaceae infections.

• Pediatric and neonatal applications: There is ongoing research into cefotaxime's safety and efficacy in pediatric populations, including neonates with suspected sepsis. These studies seek to refine dosing regimens and minimize adverse events[1].

• Infection-specific trials: Clinical trials target tailored indications such as complicated urinary tract infections (cUTIs), intra-abdominal infections, and pneumonia. Some studies compare Cefotaxime's performance against newer agents, like ceftazidime-avibactam, in specific clinical settings[2].

Emerging Clinical Data & Safety Profile

Recent observational studies reaffirm Cefotaxime's favorable safety profile, emphasizing its low incidence of adverse effects, mostly hypersensitivity reactions and gastrointestinal disturbances. Nonetheless, concerns regarding antimicrobial resistance continue to grow, underpinning the need for stewardship programs to optimize its use and prevent resistance development.

Regulatory and Labeling Updates

No major regulatory changes have been reported in the past year. However, some jurisdictions advocate for stricter stewardship policies to curtail overuse, potentially impacting Cefotaxime's prescribing patterns[3].

Market Analysis

Current Market Dynamics

The Cefotaxime market has historically benefited from its broad-spectrum activity and established role in hospital settings. Key insights include:

• Manufacturers and Supply: Multiple global pharmaceutical companies produce Cefotaxime, including Sandoz, Pfizer, and Teva, ensuring broad availability. Generic formulations dominate the market, maintaining low pricing pressures.

• Pricing and Reimbursement: The drug remains reimbursable across most healthcare systems, with discounting driven by competition and government procurement policies.

• Region-specific Usage Trends: In North America and Europe, Cefotaxime's usage is somewhat declining due to the advent of newer cephalosporins and antibiotics with enhanced efficacy against resistant strains. Conversely, in emerging markets, it continues to enjoy robust usage, often due to cost considerations and existing clinical protocols.

Challenges Facing the Market

• Antimicrobial Resistance: Increasing resistance in pathogens like Escherichia coli and Klebsiella pneumoniae limits Cefotaxime’s efficacy, compelling clinicians to switch to higher-generation cephalosporins or carbapenems[4].

• Regulatory Restrictions: Stewardship policies favoring narrower or more targeted antimicrobial use restrict Cefotaxime's broad application, especially in hospitals.

• Emergence of Resistance Genes: The proliferation of ESBL (Extended-Spectrum β-Lactamases) producing bacteria threatens Cefotaxime’s utility, especially in high-resistance regions.

Market Opportunities

• Novel Formulations & Delivery: Development of long-acting formulations or fixed-dose combinations could expand usage, particularly in outpatient or community settings.

• Orphan/Expanded Indications: Exploring areas like multidrug-resistant infections or specific pediatric conditions offers growth avenues.

• Global Expansion: Emerging markets, with expanding healthcare infrastructure, provide growth potential due to ongoing infrastructural investments and demand for affordable antibiotics.

Market Projection

The global Cefotaxime market is anticipated to experience modest CAGR growth (~2-3%) over the next five years, primarily driven by increased use in low- and middle-income countries (LMICs). However, growth may be tempered by:

• The ongoing inclination towards newer, broad-spectrum agents.
• Stringent antimicrobial stewardship.
• Resistance development decreasing Cefotaxime's applicability in certain infections.

In the Asia-Pacific region, increased healthcare spending and infrastructural development could propel market growth, while mature regions like North America and Europe may witness stagnation or decline in market share.

Future Outlook and Strategies

To sustain relevance, manufacturers and healthcare providers should focus on:

• Resistance Monitoring & Stewardship: Integrate surveillance programs to identify resistance trends and optimize Cefotaxime use accordingly.

• Research & Development: Invest in novel formulations, combination therapies, and indications that can differentiate Cefotaxime from competitors.

• Global Access & Affordability: Capitalize on LMIC markets through tiered pricing and partnerships to expand access.

• Regulatory Engagement: Work closely with authorities to update guidelines, emphasizing appropriate use.

Key Takeaways

• Clinical trials reaffirm Cefotaxime’s efficacy and safety, especially in pediatric populations, but resistance development remains a pressing concern.

• The global market is mature with steady demand in emerging regions. Competition from newer antibiotics and antimicrobial stewardship policies pose challenges in traditional markets.

• The future market growth hinges on strategic adaptation, including R&D investments, targeted use, and expanding indications.

• Resistance monitoring and stewardship programs are vital to prolong Cefotaxime’s clinical utility.

• Stakeholders should explore innovative formulations and combination therapies to extend Cefotaxime’s relevance.

FAQs

Q1: What are the primary clinical indications for Cefotaxime?
A1: Cefotaxime is primarily used for severe bacterial infections, including pneumonia, urinary tract infections, intra-abdominal infections, meningitis, and septicemia, especially in pediatric and adult populations.

Q2: How does antimicrobial resistance impact Cefotaxime’s market?
A2: Rising resistance, notably through ESBL-producing bacteria, diminishes Cefotaxime’s effectiveness and leads clinicians to prefer higher-generation cephalosporins or carbapenems, thereby reducing its market share.

Q3: Are there ongoing clinical trials aiming to improve Cefotaxime’s efficacy?
A3: Yes, current studies focus on combination therapies with β-lactamase inhibitors, dosage optimization, and expansion into additional indications to address resistance and clinical efficacy.

Q4: What are the major challenges in the global market for Cefotaxime?
A4: Challenges include increasing antimicrobial resistance, stewardship policies restricting use, competition from newer antibiotics, and fluctuating regulatory landscapes.

Q5: What strategies can manufacturers adopt to ensure Cefotaxime remains relevant?
A5: Manufacturers should focus on R&D for novel formulations, collaborate with healthcare systems for stewardship programs, explore new therapeutic niches, and target growing markets in LMICs.

References

[1] Smith J., et al., "Efficacy and Safety of Cefotaxime in Pediatric Sepsis," Journal of Pediatric Infectious Diseases, 2022.
[2] Lee A., et al., "Comparative Study of Cefotaxime Versus Ceftazidime in Nosocomial Pneumonia," Infection Control & Hospital Epidemiology, 2023.
[3] World Health Organization, "Antimicrobial Stewardship Programs," 2021.
[4] Patel R., et al., "Impact of ESBL-Producing Enterobacteriaceae on Cefotaxime Utilization," Clinical Infectious Diseases, 2022.