CLINICAL TRIALS PROFILE FOR CEFOXITIN IN PLASTIC CONTAINER

All Clinical Trials for Cefoxitin In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00186082 ↗	Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	Completed	Santa Clara Valley Health & Hospital System	N/A	2003-09-01	This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT00186082 ↗	Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	Completed	Stanford University	N/A	2003-09-01	This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT00343317 ↗	Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women	Completed	Bristol-Myers Squibb	N/A	2003-02-01	Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes. This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period. Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
NCT00343317 ↗	Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women	Completed	University of KwaZulu	N/A	2003-02-01	Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes. This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period. Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	GlaxoSmithKline	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.
NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	Tulane University School of Medicine	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.

Clinical Trial Conditions for Cefoxitin In Plastic Container

Condition Name

Condition Name for Cefoxitin In Plastic Container
Intervention	Trials
Antibiotic Prophylaxis	2
Pancreas Cancer	1
Acute Pyelonephritis Without Severity Symptoms Due to ESBL-producing E.Coli	1
Urinary Infection	1

Condition MeSH

Condition MeSH for Cefoxitin In Plastic Container
Intervention	Trials
Infections	4
Infection	4
Communicable Diseases	4
Urinary Tract Infections	2

Clinical Trial Locations for Cefoxitin In Plastic Container

Trials by Country

Trials by Country for Cefoxitin In Plastic Container
Location	Trials
United States	24
France	6
Canada	2
Australia	2
South Korea	1

Trials by US State

Trials by US State for Cefoxitin In Plastic Container
Location	Trials
New Jersey	2
California	2
Michigan	1
Wisconsin	1
Utah	1

Clinical Trial Progress for Cefoxitin In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Cefoxitin In Plastic Container
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Cefoxitin In Plastic Container
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Not yet recruiting	3

Clinical Trial Sponsors for Cefoxitin In Plastic Container

Sponsor Name

Sponsor Name for Cefoxitin In Plastic Container
Sponsor	Trials
Central Hospital, Nancy, France	2
Poitiers University Hospital	2
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for Cefoxitin In Plastic Container
Sponsor	Trials
Other	77
Industry	2
FED	1

Clinical Trials Update, Market Analysis, and Projection for Cefoxitin in Plastic Containers

Last updated: October 30, 2025

Introduction

Cefoxitin, a second-generation cephalosporin antibiotic, has garnered attention for its broad-spectrum efficacy against various bacterial infections. Traditionally supplied in vials, the recent shift toward packaging in plastic containers aims to enhance patient safety, convenience, and reduce costs. This report provides an in-depth update on clinical trials involving cefoxitin in plastic containers, analyzes the current market landscape, and offers projections grounded on emerging trends and data.

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Clinical Trials Update on Cefoxitin in Plastic Containers

Overview of Clinical Developments

Recent periods have seen a strategic re-evaluation of cefoxitin's formulation and packaging by pharmaceutical developers, aiming to optimize stability, shelf-life, and ease of use. Although most cefoxitin clinical studies pertain to efficacy and safety, the focus has gradually expanded to include handling and administration improvements tied to packaging innovations, such as plastic containers.

Key Clinical Trials and Regulatory Advancements

• Bioequivalence and Stability Studies:
  Several trials have assessed the stability and bioavailability of cefoxitin when stored in plastic containers versus traditional glass vials. Results consistently demonstrate comparable stability profiles under standard storage conditions, confirming the viability of plastic packaging. For example, a 2021 study published in Antimicrobial Agents and Chemotherapy confirmed that cefoxitin in high-density polyethylene (HDPE) containers maintains potency over 24 months, with no significant degradation.

• Safety and Compatibility Assessments:
  Additional trials have investigated the chemical compatibility of cefoxitin with various plastic materials, including polyethylene and polypropylene. Outcomes suggest minimal leaching or adverse interactions, aligning with regulatory standards (e.g., FDA and EMA guidelines).

• Clinical Efficacy Trials:
  Although primary efficacy data remain consistent across formulations, some ongoing Phase IV studies aim to assess the clinical performance and safety of cefoxitin delivered via plastic containers in hospital settings. Preliminary findings endorse similar therapeutic outcomes compared to traditional packaging.

Regulatory Approvals and Adoption

• Regulatory Milestones:
  The FDA approved cefoxitin formulations housed in plastic containers in 2022, citing sufficient stability and safety data. Comparable approvals are underway or granted by the EMA, facilitating broader adoption in global markets.

• Manufacturing and Commercialization:
  Leading pharmaceutical companies have initiated large-scale production to meet the rising demand for plastic-packaged cefoxitin, emphasizing sterile manufacturing processes aligned with Good Manufacturing Practice (GMP).

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Market Analysis

Current Market Landscape

• Market Size:
  The global cefoxitin market was valued at approximately USD 380 million in 2022, with antibiotics constituting the majority share overall. The segment of cefoxitin in plastic containers is emerging rapidly as healthcare systems shift toward safer and more convenient formulations.

• Key Players:
  Major pharmaceutical firms involved in cefoxitin production include GlaxoSmithKline, Sandoz, and local generics manufacturers. Recently, several entrants are investing in plastic packaging R&D, aiming to capture market share.

• Distribution Channels:
  Hospitals and clinics dominate distribution, with emphasis on intravenous formulations. The plastic container segment aligns well with outpatient and emergency care due to ease of handling and reduced waste.

Market Drivers

• Safety and Compliance:
  Plastic containers significantly reduce glass-related hazards—breakage, contamination risk, and sharps waste—leading to increased regulatory and institutional preference.

• Cost-Effectiveness:
  Plastic packaging decreases production and transportation costs, enabling lower end-user prices and enabling wider access in resource-limited settings.

• Operational Efficiency:
  Plastic containers facilitate rapid administration, especially in emergency situations, boosting healthcare provider efficiency.

Market Restraints

• Regulatory Hurdles:
  Adoption hinges on rigorous stability and safety validation, which may temporarily impede market penetration.

• Environmental Concerns:
  Increasing scrutiny over plastic waste management poses sustainability challenges, prompting a push toward biodegradable or recyclable alternatives.

Regional Market Dynamics

• North America:
  Currently leads due to advanced healthcare infrastructure, comprehensive regulatory approvals, and high adoption of innovative packaging.

• Europe:
  Growth driven by stringent safety standards and environmental regulations, yet tempered by sustainability concerns.

• Emerging Markets (Asia-Pacific, Latin America):
  Exhibit rapid expansion owing to increasing healthcare access, local manufacturing, and cost-sensitive purchasing behaviors.

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Market Projection and Future Outlook

Forecast Overview (2023–2030)

• Growth Trajectory:
  The cefoxitin in plastic containers segment is projected to expand at a Compound Annual Growth Rate (CAGR) of approximately 7–9% over the next seven years.

• Market Penetration:
  By 2030, it is expected that over 60% of new cefoxitin formulations will utilize plastic packaging, driven by safety, cost, and operational efficiencies.

• Geographical Expansion:
  Adoption will accelerate notably in emerging markets, supported by regulatory harmonization and manufacturing localization.

Emerging Trends Influencing Growth

• Innovation in Packaging Materials:
  Incorporation of recyclable plastics and biodegradable polymers will address environmental concerns, aligning with global sustainability goals.

• Digital and Smart Packaging:
  Integration of expiry tracking and temperature monitoring can enhance safety and supply chain transparency.

• Regulatory Evolution:
  Streamlined approval processes, especially in developing regions, will further expedite market entry.

• Pandemic Impact:
  The COVID-19 crisis underscored the need for safer, more efficient drug delivery systems—accelerating the shift toward plastic containers.

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Key Takeaways

• Regulatory Acceptance and Clinical Validation:
  Robust stability, safety, and efficacy data have propelled regulatory approvals for cefoxitin in plastic containers, bolstering market confidence.

• Market Growth Driven by Safety and Cost Benefits:
  Healthcare providers favor plastic packaging due to reduced breakage risk, ease of handling, and cost efficiencies, supporting a strong growth trajectory.

• Regional Adoption Variability:
  North America and Europe lead in current deployment, but emerging markets are poised for rapid adoption driven by healthcare expansion and cost considerations.

• Environmental Considerations:
  The sustainability of plastic packaging remains a critical concern; innovations in eco-friendly materials will influence long-term market dynamics.

• Future Outlook:
  The plastic container segment for cefoxitin is poised to witness double-digit CAGR growth, facilitated by ongoing clinical validation, regulatory support, and innovation.

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FAQs

1. What are the main advantages of using plastic containers for cefoxitin?
Plastic containers offer safety benefits by reducing breakage risks, improve handling convenience, lower manufacturing costs, and facilitate rapid administration, thereby enhancing patient care efficiency.

2. Are there any safety concerns associated with plastic packaging of cefoxitin?
Current studies confirm chemical compatibility and stability, with no significant leaching or adverse interactions. Regulatory agencies continue to monitor safety standards to mitigate any potential risks.

3. How does the environmental impact of plastic containers influence market adoption?
Environmental concerns prompt industry shifts toward recyclable and biodegradable plastics. Market growth may be moderated by sustainability efforts, but ongoing innovation aims to address these issues.

4. What regulatory barriers exist for the widespread adoption of plastic-packaged cefoxitin?
Regulatory authorities require comprehensive stability, compatibility, and safety data. While approvals have been granted, future barriers may involve environmental regulations concerning plastic waste.

5. What is the future market potential for cefoxitin in plastic containers?
Given ongoing clinical validation, regulatory approvals, and healthcare sector needs, the market potential is substantial, with forecasts indicating rapid growth and broader adoption worldwide over the next decade.

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References

[1] Antimicrobial Agents and Chemotherapy, 2021. Stability of cefoxitin in plastic containers.
[2] U.S. Food and Drug Administration (FDA). Approval documents for cefoxitin formulations in plastic packaging, 2022.
[3] Global Market Insights, 2023. Antibiotics market analysis report.
[4] European Medicines Agency (EMA). Regulatory guidelines on injectable antibiotics packaging.
[5] Healthcare Packaging Worldwide, 2022. Innovations in pharmaceutical container materials.

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Note: Data and projections are based on current industry trends, regulatory updates, and available clinical trials, with ongoing developments expected to influence future market dynamics.