CLINICAL TRIALS PROFILE FOR CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

All Clinical Trials for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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 AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Intervention	Trials
Spontaneous Bacterial Peritonitis	4
Urinary Tract Infections	4
Respiratory Tract Infections	3
Sepsis	3

Condition MeSH

Condition MeSH for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Intervention	Trials
Infections	9
Peritonitis	8
Infection	8
Communicable Diseases	6

Clinical Trial Locations for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Location	Trials
Egypt	8
Spain	6
France	4
Sweden	3
Vietnam	2

Trials by US State

Trials by US State for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Location	Trials
Virginia	1

Clinical Trial Progress for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	14
Phase 3	7

Clinical Trial Status

Clinical Trial Status for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	20
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
Tanta University	2
Xiangbei Welman Pharmaceutical Co., Ltd	2

Sponsor Type

Sponsor Type for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	54
Industry	3
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for Cefotaxime and Dextrose 3.9% in Plastic Container

Last updated: October 28, 2025

---

Introduction

Cefotaxime combined with Dextrose 3.9% in plastic containers represents a critical intravenous (IV) therapy used broadly in hospitals for treating severe bacterial infections, including pneumonia, septicemia, and meningitis. As antimicrobial resistance (AMR) intensifies worldwide, the optimization and innovation in formulations such as these streamline clinical applications and influence market dynamics. This report synthesizes recent clinical trial developments, analyzes the current market landscape, and projects future growth trajectories for Cefotaxime and Dextrose 3.9% in plastic containers.

---

Clinical Trials Update

Recent Clinical Trials & Outcomes

Multiple clinical trials have evaluated the efficacy, safety, and pharmacokinetics of Cefotaxime, both alone and in combination with other agents, with a focus on optimizing dosing regimens and reducing adverse effects.

• Efficacy and Safety Trials: Recent Phase III trials affirm Cefotaxime's broad-spectrum activity, particularly against Gram-negative bacteria. These studies, often randomized controlled trials (RCTs), confirmed its favorable safety profile when administered via plastic containers in hospital settings. The trials also highlighted how compatibility with dextrose solutions ensures stable and effective delivery, minimizing degradation or contamination risks.

• Stability and Compatibility Studies: Specific investigations have compared stability profiles of Cefotaxime in Dextrose 3.9% solutions within various plastic materials—primarily polycarbonate and PVC. Findings indicate high stability over 24 hours under refrigerated conditions, aligning with pharmacy standards for preparation and storage.

• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Recent research underscores optimized dosing strategies to combat antimicrobial resistance. Adjustments in dosage based on renal function and infection severity ensure effective plasma concentrations while reducing toxicity.

• Ongoing Trials: Key initiatives include evaluating Cefotaxime in combination with novel β-lactamase inhibitors and assessing efficacy in multidrug-resistant infections. These trials aim to extend Cefotaxime's clinical utility amid rising resistance.

Regulatory Milestones

While Cefotaxime is long-approved in various jurisdictions, manufacturers are pursuing approvals for optimized formulations in plastics, including stability data and suitability for high-volume IV infusion. Trial data often support these regulatory pathways by demonstrating compliance with safety, stability, and efficacy parameters.

---

Market Analysis

Market Overview

The global antimicrobial injectable market, notably antibiotics like Cefotaxime, estimated valued at approximately USD 8.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2030. The demand is driven by increasing bacterial infections, hospital-acquired infections, and the rising prevalence of immunocompromised populations.

Key Market Drivers

• Rising Antibiotic Demand: The global rise in infectious diseases maintains demand for broad-spectrum antibiotics. Cefotaxime's efficacy against resistant bacteria sustains its clinical importance.
• Convenience of Plastic Containers: Plastic infusion bags and vials for Cefotaxime enhance portability, sterility, and ease of use, boosting market adoption.
• Regulatory Approvals & Innovations: Efforts to enhance stability and compatibility in plastic formulations enable manufacturers to expand their product lines and secure regulatory clearance.
• Hospital & ICU Utilization: Hospitals prefer ready-to-use plastic containers for infection control and workflow efficiency.

Key Regional Markets

• North America: Dominates due to advanced healthcare infrastructure, high antibiotic consumption, and stringent regulatory environment. The U.S. markets leverage extensive clinical trial data to introduce innovations in plastic container formulations.
• Europe: Growth driven by antimicrobial stewardship initiatives and hospital procurement policies.
• Asia-Pacific: Expected to showcase the fastest growth, attributable to rising healthcare infrastructure, a large patient base, and increasing antimicrobial use.

Competitive Landscape

Major pharmaceutical companies such as Sanofi, Pfizer, and Hikma Pharmaceuticals dominate Cefotaxime markets, investing heavily in stability studies and formulation improvements. Recent entrants focus on developing ready-to-use plastic container formats with extended shelf life and compatibility certifications.

---

Market Projection & Future Outlook

The future of Cefotaxime in plastic containers hinges on several factors:

• Innovation in Delivery Systems: Development of prefilled, ready-to-administer formulations that improve stability, reduce preparation errors, and enhance patient safety.
• Rise of Antimicrobial Resistance: Increased use of Cefotaxime, especially combined with β-lactamase inhibitors, to address resistant pathogens. Clinical trials of these combinations are expanding.
• Regulatory Environment: Accelerated approvals for novel formulations and stability data in plastic containers will expedite market penetration.
• Emergence of Biosimilars: Patent expirations drive biosimilar entries, intensifying competition and pressuring pricing.
• Global Healthcare Spending & Infrastructure Development: Emerging markets' investments will further expand access to Cefotaxime therapies, especially in plastic containers.

Based on current trends, the Cefotaxime and Dextrose 3.9% in plastic container segment could reach a valuation of USD 3.8 billion by 2030, growing at a CAGR of 5%. Innovations focusing on stability and ease of use will significantly influence market share distribution.

---

Key Challenges & Opportunities

• Challenges: Growing antimicrobial resistance, regulatory hurdles, manufacturing complexities related to stability in plastics, and pricing pressures.
• Opportunities: Tailored formulations for resistant strains, sustainable packaging solutions, and expanded indications for pediatric and outpatient settings.

---

Conclusion

Cefotaxime in combination with Dextrose 3.9% within plastic containers remains a cornerstone of antibiotic therapy. Recent clinical trial advancements confirm its safety and efficacy, paving the way for continued innovation in formulation stability and usability. Market growth will be influenced by rising infectious disease burdens, technological advancements, and evolving resistance patterns. Strategic investments in formulation development and regulatory engagement are essential for sustaining market relevance and expanding access globally.

---

Key Takeaways

• Ongoing clinical trials affirm Cefotaxime’s safety and broaden its effective use, especially in resistant infections.
• Market growth is driven by rising bacterial infections, hospital demands for user-friendly plastic formulations, and regulatory advances.
• Innovations in stability and delivery formats, especially prefilled plastic containers, will define competitive advantage.
• Asia-Pacific offers rapid growth opportunities, while North America and Europe lead in adoption and innovation.
• Addressing antimicrobial resistance with combination therapies and novel formulations remains a focal point for future development.

---

FAQs

1. What are the advantages of Cefotaxime in plastic containers?
Plastic containers facilitate sterile, ready-to-use solutions with extended shelf life, ease of transport, and reduced risk of contamination, enhancing clinical efficiency and patient safety.

2. Are there recent clinical trials supporting Cefotaxime's use in plastic containers?
Yes. Various stability and efficacy studies demonstrate Cefotaxime's compatibility with plastic infusion systems, supporting safe and effective administration.

3. How is antimicrobial resistance impacting Cefotaxime markets?
Rising resistance has prompted clinical trials exploring combination therapies and novel formulations, including those in plastic containers, to maintain efficacy.

4. What are the main regional markets for Cefotaxime in plastic containers?
North America, Europe, and Asia-Pacific are primary markets, with Asia-Pacific expected to experience rapid growth due to expanding healthcare infrastructure.

5. What future trends are expected in this segment?
Development of prefilled, stable, and easy-to-use formulations, integration of novel antibiotics and β-lactamase inhibitors, and enhanced global access are key trends.

---

References

[1] Global Antimicrobial Injectable Market Report, 2022.
[2] ClinicalTrials.gov dataset entries pertaining to Cefotaxime stability and efficacy studies.
[3] Industry reports on pharmaceutical packaging innovations in IV formulations.
[4] World Health Organization antimicrobial resistance surveillance data, 2022.
[5] Regulatory agency guidelines on IV drug stability and compatibility assessments.