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Last Updated: April 10, 2025

CLINICAL TRIALS PROFILE FOR CEFOXITIN IN PLASTIC CONTAINER


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All Clinical Trials for CEFOXITIN IN PLASTIC CONTAINER

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00856089 ↗ Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization Withdrawn GlaxoSmithKline Phase 4 2009-05-01 The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of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.
NCT00856089 ↗ Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization Withdrawn Ochsner Health System 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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for CEFOXITIN IN PLASTIC CONTAINER

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2Antibiotic ProphylaxisAntibiotic Prophylaxis SurgeryMetastatic CancerPuerperal Sepsis[disabled in preview]
Condition Name for CEFOXITIN IN PLASTIC CONTAINER
Intervention Trials
Antibiotic Prophylaxis 2
Antibiotic Prophylaxis Surgery 1
Metastatic Cancer 1
Puerperal Sepsis 1
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Condition MeSH

4442000.511.522.533.54InfectionsInfectionCommunicable DiseasesUrinary Tract Infections[disabled in preview]
Condition MeSH for CEFOXITIN IN PLASTIC CONTAINER
Intervention Trials
Infections 4
Infection 4
Communicable Diseases 4
Urinary Tract Infections 2
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Clinical Trial Locations for CEFOXITIN IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for CEFOXITIN IN PLASTIC CONTAINER
Location Trials
United States 23
France 6
Canada 2
Australia 2
United Kingdom 1
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Trials by US State

+
Trials by US State for CEFOXITIN IN PLASTIC CONTAINER
Location Trials
New Jersey 2
California 2
Oregon 1
Ohio 1
North Carolina 1
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Clinical Trial Progress for CEFOXITIN IN PLASTIC CONTAINER

Clinical Trial Phase

22.2%16.7%11.1%50.0%023456789Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for CEFOXITIN IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Phase 2/Phase 3 2
[disabled in preview] 9
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Clinical Trial Status

27.8%22.2%16.7%33.3%033.544.555.56CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for CEFOXITIN IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Completed 5
Terminated 4
Unknown status 3
[disabled in preview] 6
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Clinical Trial Sponsors for CEFOXITIN IN PLASTIC CONTAINER

Sponsor Name

trials011223344556Poitiers University HospitalAssistance Publique - Hôpitaux de ParisThe University of Queensland[disabled in preview]
Sponsor Name for CEFOXITIN IN PLASTIC CONTAINER
Sponsor Trials
Poitiers University Hospital 2
Assistance Publique - Hôpitaux de Paris 2
The University of Queensland 2
[disabled in preview] 5
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Sponsor Type

97.4%001020304050607080OtherIndustry[disabled in preview]
Sponsor Type for CEFOXITIN IN PLASTIC CONTAINER
Sponsor Trials
Other 75
Industry 2
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Cefoxitin in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Cefoxitin, a semi-synthetic, broad-spectrum cephalosporin antibiotic, is widely used in clinical settings for treating various bacterial infections. The packaging and delivery of cefoxitin, particularly in plastic containers, play a crucial role in its efficacy, safety, and market viability. Here, we delve into the clinical trials, market analysis, and future projections for cefoxitin packaged in plastic containers.

Clinical Trials and Usage

Efficacy and Safety

Cefoxitin is commonly administered intravenously, and its packaging in plastic containers, such as the DUPLEX® Container, ensures ease of use and safety. The DUPLEX® Container is a flexible dual-chamber container that separates the cefoxitin sodium from the dextrose solution until activation, preventing any potential interactions and ensuring sterility[1].

Administration Guidelines

The administration of cefoxitin from these containers is strictly regulated to avoid complications such as air embolism. It must be administered intravenously over approximately 30 minutes, and other intravenous solutions should be temporarily discontinued during its infusion. Additionally, cefoxitin should not be mixed with aminoglycoside solutions due to potential interactions[1].

Market Analysis

Global Market Size and Growth

The market for cefoxitin sodium injection is growing rapidly, with a projected Compound Annual Growth Rate (CAGR) of 11.5% from 2024 to 2030. The market size was valued at USD 100 million in 2023 and is expected to reach USD 250 million by the end of 2030[5].

Key Players

The cefoxitin sodium injection market is dominated by several key players, including Apotex, Fresenius Kabi, Hikma, Sagent, WG Critical Care, B Braun, Teva, Pfizer, Shenzhen Zhijun Pharmaceutical, Luoxin Group, Lijian Pharma, and Qilu Pharmaceutical. These companies are driving innovation and expansion in the market[5].

Regional Market Dynamics

The market is segmented geographically into North America, Europe, Asia Pacific, and the rest of the world. Asia Pacific is a significant region due to its large population and growing healthcare needs, while North America and Europe also contribute substantially to the market due to their advanced healthcare systems and high demand for antibiotics[5].

Packaging and Logistics

Advantages of Plastic Containers

Plastic containers have become the preferred choice for packaging pharmaceuticals, including cefoxitin, due to their cost-effectiveness, ease of use, resistance to leakage, and lightweight nature. Unlike glass containers, plastic containers are chemically inert and resistant to corrosion, which helps protect the drugs and increases their shelf-life[2].

Market Trends in Plastic Containers

The global plastic containers market is projected to grow from USD 218.04 billion in 2024 to USD 344.79 billion by 2032, with a CAGR of 5.9%. This growth is driven by the increasing demand from the pharmaceutical, FMCG, and food industries. The adoption of recycled plastics and bioplastics is also expected to contribute to market growth[2].

Clinical Trials Supply and Logistics

U.S. Clinical Trials Market

The U.S. clinical trials supply and logistics market, which includes the packaging and delivery of drugs like cefoxitin, is estimated to grow significantly. The oncology segment, in particular, is expected to grow at a CAGR of 7.6% from 2024 to 2030, driven by the increasing need for clinical trials in cancer therapeutics. Companies like Catalent, Inc., PCI Pharma Service, and Thermo Fisher Scientific, Inc. are key players in this market[3].

Resistance and Diagnostic Markers

Cefoxitin as a Surrogate Marker

Cefoxitin is also used as a surrogate marker for detecting methicillin resistance in Staphylococcus aureus. Studies have shown that testing with cefoxitin is highly accurate in distinguishing methicillin-resistant strains from susceptible ones, using both disc diffusion and agar dilution methods[4].

Future Projections

Market Expansion

The growing demand for antibiotics, coupled with advancements in packaging technology, is expected to drive the market for cefoxitin in plastic containers. The increasing focus on patient compliance and the need for safe, efficient drug delivery systems will further fuel market growth.

Innovations in Packaging

The adoption of innovative packaging solutions, such as the DUPLEX® Container, will continue to enhance the safety and efficacy of cefoxitin administration. The use of recycled plastics and bioplastics is also expected to become more prevalent, aligning with global sustainability initiatives.

Key Takeaways

  • Growing Market: The cefoxitin sodium injection market is projected to grow at a CAGR of 11.5% from 2024 to 2030.
  • Plastic Containers: Plastic containers are preferred for their cost-effectiveness, ease of use, and resistance to leakage.
  • Clinical Trials: The U.S. clinical trials supply and logistics market is expected to grow, driven by the oncology segment.
  • Resistance Detection: Cefoxitin is used as a surrogate marker for detecting methicillin resistance in Staphylococcus aureus.
  • Future Trends: Innovations in packaging and the adoption of sustainable materials will drive market growth.

FAQs

Q: What is the projected growth rate of the cefoxitin sodium injection market?

The cefoxitin sodium injection market is projected to grow at a CAGR of 11.5% from 2024 to 2030[5].

Q: Why are plastic containers preferred for packaging cefoxitin?

Plastic containers are preferred due to their cost-effectiveness, ease of use, resistance to leakage, and lightweight nature. They are also chemically inert and resistant to corrosion[2].

Q: How is cefoxitin administered from a DUPLEX® Container?

Cefoxitin from a DUPLEX® Container is administered intravenously over approximately 30 minutes. Other intravenous solutions should be temporarily discontinued during its infusion, and the container should be inspected for leaks and particulate matter before use[1].

Q: What is the role of cefoxitin in detecting methicillin resistance?

Cefoxitin is used as a surrogate marker for detecting methicillin resistance in Staphylococcus aureus. It is highly accurate in distinguishing methicillin-resistant strains from susceptible ones using disc diffusion and agar dilution methods[4].

Q: Which regions are driving the growth of the cefoxitin sodium injection market?

The market is driven by regions such as North America, Europe, and Asia Pacific, with Asia Pacific being a significant contributor due to its large population and growing healthcare needs[5].

Sources

  1. Drugs.com: Cefoxitin and Dextrose Injection: Package Insert / Prescribing Info.
  2. Fortune Business Insights: Plastic Containers Market Size, Share | Growth Report [2032].
  3. Grand View Research: U.S. Clinical Trials Supply And Logistics Market | Industry Report, 2030.
  4. Oxford Academic: Cefoxitin resistance as a surrogate marker for the detection of methicillin resistance.
  5. Verified Market Reports: Cefoxitin Sodium Injection Market Size, Share, Growth | Global.

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