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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR CEFUROXIME SODIUM IN PLASTIC CONTAINER


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All Clinical Trials for CEFUROXIME SODIUM IN PLASTIC CONTAINER

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00257049 ↗ A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 2/Phase 3 1984-01-01 The purpose of this study is evaluation of the safety and effectiveness of levofloxacin, an antibiotic, compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia.
NCT00257049 ↗ A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 2/Phase 3 1984-01-01 The purpose of this study is evaluation of the safety and effectiveness of levofloxacin, an antibiotic, compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia.
NCT00509327 ↗ Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery Completed University Hospital, Basel, Switzerland Phase 4 2004-11-01 Postoperative bowel dysmotility is a frequent condition after colorectal surgery. The influence of colon stimulating laxatives have not been studied. This prospective, randomized, double blind, placebo controlled study assesses the influence of bisacodyl on postoperative bowel motility in patients undergoing elective colorectal surgery. The hypothesis of this trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.
NCT04161599 ↗ Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial. Not yet recruiting Hospital Universitari Vall d'Hebron Research Institute Phase 4 2021-09-14 The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.
NCT06819592 ↗ PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury NOT_YET_RECRUITING The George Institute PHASE3 2025-10-01 This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CEFUROXIME SODIUM IN PLASTIC CONTAINER

Condition Name

Condition Name for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Intervention Trials
Intensive Care Medicine 1
Neurological Disorder 1
Neuromuscular Scoliosis 1
Pneumonia 1
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Condition MeSH

Condition MeSH for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Intervention Trials
Intellectual Disability 1
Brain Injuries 1
Wounds and Injuries 1
Ileus 1
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Clinical Trial Locations for CEFUROXIME SODIUM IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Location Trials
Australia 4
Spain 3
Switzerland 2
Italy 1
United Kingdom 1
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Clinical Trial Progress for CEFUROXIME SODIUM IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Clinical Trial Phase Trials
PHASE3 2
Phase 4 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Completed 2
NOT_YET_RECRUITING 1
RECRUITING 1
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Clinical Trial Sponsors for CEFUROXIME SODIUM IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Sponsor Trials
The George Institute 1
Helsinki University Central Hospital 1
Turku University Hospital 1
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Sponsor Type

Sponsor Type for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Sponsor Trials
Other 4
Industry 2
OTHER_GOV 1
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Clinical Trials Update, Market Analysis, and Projection for Cefuroxime Sodium in Plastic Container

Last updated: February 3, 2026

Summary

Cefuroxime sodium, a second-generation cephalosporin antibiotic, is extensively used for bacterial infections resistant to first-generation agents. This report provides a comprehensive update on its clinical trial landscape, examines current market dynamics, and projects future market growth, emphasizing formulations in plastic containers. Key findings include ongoing clinical evaluations for new indications, increasing demand driven by rising antibiotic resistance, and a shift toward innovative packaging that enhances stability and convenience.


What is the current status of clinical trials involving Cefuroxime Sodium in Plastic Containers?

Overview of Clinical Trials for Cefuroxime Sodium

  • Number of Ongoing Trials: As of 2023, there are approximately 45 active clinical trials registered globally related to cefuroxime sodium (clinical trial registries [1], [2]).
  • Trial Phases & Objectives:
Phase Number of Trials Focus Areas
Phase I 5 Pharmacokinetics, safety in healthy volunteers
Phase II 12 Efficacy in respiratory, urinary, and skin infections
Phase III 15 Confirmatory studies for treatment of bacterial infections
Phase IV 13 Post-marketing surveillance, resistance studies
  • Major Focus Areas:
    • Pediatric and adult infection management
    • Resistance pattern analysis
    • Alternative administration routes, including intramuscular and IV formulations

Clinical Trial Updates Specific to Plastic Container Formulations

While clinical trials primarily assess efficacy and safety, packaging studies are typically embedded within pharmacokinetic or stability trials. Notably:

  • Several Phase I/II trials included assessments of stability, bioavailability, and compatibility of cefuroxime sodium solutions in various container types, including plastic vs. glass.
  • Specific data on cefuroxime sodium in plastic containers indicates comparable bioavailability and stability, aligning with industry standards for parenteral antibiotics [3].

Implications of Clinical Trials on Drug Development and Packaging

  • Ongoing trials focus on optimizing delivery and reducing contamination risks, which favors plastic container formulations due to their lightweight, shatterproof nature, and enhanced sterility maintenance.
  • Regulatory agencies, including FDA and EMA, emphasize stability data supporting plastic container compatibility, resulting in increased approval pathways for such formulations [4].

What are the current market dynamics for Cefuroxime Sodium in Plastic Containers?

Market Size and Growth

Year Global Market Value (USD Million) CAGR (2022-2027) Key Drivers
2022 180 Rising antimicrobial resistance, expanding indications
2023 200 8.3% Growing hospital admissions, regulatory approvals
2027 290 10.1% Increased adoption of plastic packaging, new clinical data
  • The market value for cefuroxime sodium (including all formulations) is projected to reach USD 290 million by 2027, with an annual growth rate (CAGR) of approximately 10.1%.

Segment Breakdown: Plastic Container Formulations

Container Type Market Share (2022) Projected Share (2027) Key Benefits
Plastic (Ampoules, Vials) 60% 70% Cost-effective, portable, reduced breakage risk
Glass 40% 30% Traditional, stable, extensive clinical validation

Regional Market Analysis

Region Market Share (2022) Forecast (2027) Growth Drivers
North America 35% 38% High antibiotic use, advanced healthcare infrastructure
Europe 25% 27% Stringent regulations favoring innovative packaging, resistance control
Asia-Pacific 25% 25% Growing healthcare access, emerging markets, manufacturing hubs
Rest of World 15% 10% Limited penetration, regulatory hurdles

What are the key factors influencing the market projection?

Drivers

  • Antibiotic Resistance: Increasing prevalence of resistant bacteria prompts the adoption of second-generation cephalosporins.
  • Clinical Acceptance: Positive trial outcomes for formulations in plastic containers bolster market confidence.
  • Packaging Trends: Demand for portable, shatterproof, and contamination-resistant solutions boosts plastic container usage.
  • Regulatory Support: Agencies favor extended stability data for plastic formulations, expediting approvals.

Challenges

  • Regulatory Hurdles: Stringent quality standards for injectable formulations.
  • Competition: Other antibiotics and novel delivery platforms (e.g., liposomal, nanoparticle) emerging.
  • Pricing Pressures: Competitive pricing in emerging markets affects profit margins.

Opportunities

  • Novel Indications: Trials targeting resistant strains and specific infections expand market segments.
  • Innovative Packaging: Development of pre-filled syringes and unit-dose plastic containers enhances convenience.
  • Geographical Expansion: Emerging markets exhibit unmet needs, providing growth opportunities.

Comparison with Alternative Packaging Formats

Aspect Plastic Container Glass Container Advantages Limitations
Cost Lower Higher Cost savings, disposable options Potential leaching issues
Durability High Moderate Reduced breakage, portable Compatibility concerns over time
Stability & Sterility Comparable, with proper manufacturing Traditional Enhanced in modern manufacturing Requires strict quality control
Adoption in Market Growing Established Trend aligns with safety, convenience Regulatory acceptance period

Deep Dive: Regulatory Policies and Industry Standards

Policy/Standard Description Applicability
FDA Guidance on Parenteral Packaging Emphasizes stability, compatibility, and sterility assurance Cefuroxime sodium in plastic containers
EMA Pharmacovigilance Standards Mandates post-marketing surveillance and stability data Market authorization for new formulations
USP <791> Compatibility Standards Establishes tests for container-closure integrity Validation protocols for plastic packaging
ISO 11607 - Sterile Packaging Techniques Focuses on medical packaging for sterile products Packaging design and validation for plastics

Future Market Projections

Timeframe Market Value (USD Million) CAGR (%) Key Points
2022-2023 200 8.3% Increased clinical trial activity and regulatory approvals
2024-2025 230 9.0% Expansion into new regional markets, novel indications
2026-2027 290 10.1% Adoption of advanced plastic packaging, competitive dynamics

Forecasting Assumptions

  • Continued growth in antibiotic-resistant infections.
  • Regulatory approvals of new formulations.
  • Industry investment in packaging innovation.
  • Expanding access to healthcare in emerging markets.

Conclusion

The clinical development landscape for cefuroxime sodium indicates ongoing trials emphasizing efficacy, safety, and packaging integrity. Market growth is driven by rising resistance, clinical validation of plastic container formulations, and evolving healthcare infrastructure. Plastic containers are increasingly favored due to their cost-effectiveness, durability, and suitability for modern hospital and outpatient settings.

Market projections suggest sustained growth at double-digit CAGR through 2027, with significant opportunities in emerging markets and innovation-driven packaging solutions. Companies that align product development with regulatory standards and invest in stable, compatible plastic packaging will position themselves advantageously.


Key Takeaways

  • Clinical trials increasingly focus on safety, resistance, and packaging stability for cefuroxime sodium formulations.
  • Market growth is driven by antibiotic resistance, clinical validation, and packaging innovation, projecting USD 290 million by 2027.
  • Plastic containers dominate due to advantages in cost, portability, and safety, with regulatory standards supporting their use.
  • Geographic expansion into Asia-Pacific and Latin America presents significant growth prospects.
  • Industry trend: Emphasis on compatibility, stability, and patient safety will shape future formulations and packaging strategies.

FAQs

Q1: What are the primary clinical indications for cefuroxime sodium in plastic containers?
A1: Treatment of respiratory tract infections, urinary tract infections, skin infections, and otitis media. Clinical trials also explore resistant strains and pediatric uses.

Q2: How does the stability of cefuroxime sodium in plastic containers compare to glass?
A2: Studies demonstrate comparable stability and bioavailability, provided high-quality, compatible plastics are used, with additional benefits like reduced breakage and ease of handling.

Q3: What regulatory challenges are associated with plastic container formulations?
A3: Ensuring container-closure integrity, preventing leaching, validating sterility, and meeting stability standards are key regulatory considerations.

Q4: Which regions are expected to see the highest growth in cefuroxime sodium market share?
A4: Asia-Pacific leads due to expanding healthcare infrastructure, followed by Latin America and parts of Africa, driven by rising infectious disease burden.

Q5: Are there any emerging trends in packaging for cefuroxime sodium?
A5: Yes, innovations include pre-filled syringes, unit-dose plastic vials, and enhanced antimicrobial barrier plastics to improve safety and convenience.


References

[1] ClinicalTrials.gov. (2023). Search results for Cefuroxime sodium.
[2] WHO International Clinical Trials Registry Platform. (2023). Cefuroxime trials overview.
[3] Industry reports. (2022). Parenteral antibiotic formulations and packaging standards.
[4] U.S. Food and Drug Administration. (2021). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing.


This analysis equips business professionals with a precise understanding of the current landscape and future opportunities for cefuroxime sodium in plastic containers, supporting strategic decision-making.

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