CLINICAL TRIALS PROFILE FOR CEFOXITIN

All Clinical Trials for CEFOXITIN

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NCT00856089 ↗	Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization	Withdrawn	GlaxoSmithKline	Phase 4	2009-05-01	The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of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

Clinical Trial Conditions for CEFOXITIN

Condition Name

Condition Name for CEFOXITIN
Intervention	Trials
Antibiotic Prophylaxis	2
Endometritis	1
Pancreaticoduodenectomy	1
Antibiotherapy	1

Condition MeSH

Condition MeSH for CEFOXITIN
Intervention	Trials
Infections	4
Infection	4
Communicable Diseases	4
Urinary Tract Infections	2

Clinical Trial Locations for CEFOXITIN

Trials by Country

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−

Trials by Country for CEFOXITIN
Location	Trials
United States	23
France	6
Canada	2
Australia	2
China	1

Trials by US State

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−

Trials by US State for CEFOXITIN
Location	Trials
New Jersey	2
California	2
Wisconsin	1
Utah	1
Texas	1

Clinical Trial Progress for CEFOXITIN

Clinical Trial Phase

Clinical Trial Phase for CEFOXITIN
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for CEFOXITIN
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Not yet recruiting	3

Clinical Trial Sponsors for CEFOXITIN

Sponsor Name

Sponsor Name for CEFOXITIN
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
The University of Queensland	2
Central Hospital, Nancy, France	2

Sponsor Type

Sponsor Type for CEFOXITIN
Sponsor	Trials
Other	75
Industry	2

Cefoxitin: Clinical Trials, Market Analysis, and Projections

Introduction to Cefoxitin

Cefoxitin is a cephamycin antibiotic, a subclass of cephalosporins, known for its efficacy against a wide range of bacterial infections, including those caused by aerobic and anaerobic bacteria. Here, we will delve into the clinical trials, market analysis, and future projections for this versatile antibiotic.

Clinical Efficacy and Safety

Early Clinical Trials

In early clinical trials, cefoxitin demonstrated significant efficacy in treating various infections. A study involving 143 patients, 67% of whom were seriously ill, showed a cure or improvement rate of 93% when treated with cefoxitin. This study also highlighted the drug's effectiveness against anaerobic infections, with all 14 patients with anaerobic or predominantly anaerobic infections showing improvement or cure[1].

Another study focused on the treatment of serious infections involving aerobic and anaerobic bacteria. It found that cefoxitin was efficacious and safe, with 23 out of 36 patients achieving clinical and bacteriological cure. The drug was particularly effective against Bacteroides fragilis, with 6 out of 7 patients being cured[3].

Recent Clinical Applications

More recent studies have reinforced cefoxitin's clinical utility. A retrospective observational cohort study evaluated the impact of using cefoxitin as first-line monotherapy for intra-amniotic infections (IAIs) and endometritis. The study found that the use of cefoxitin was noninferior to traditional antimicrobial therapy regimens in preventing serious clinical events postdelivery[4].

Adverse Effects

While cefoxitin has shown strong efficacy, it is not without adverse effects. Common side effects include drug eruptions, asymptomatic serum transaminase elevation, leukopenia, and eosinophilia. Severe thrombophlebitis was also reported in 5% of the patients. However, no permanent or serious adverse reactions were encountered[1][3].

Market Analysis

Global Market Size and Growth

The global cefoxitin market is experiencing significant growth. As of 2023, the market size was valued at USD 100 million and is projected to reach USD 250 million by 2030, with a compound annual growth rate (CAGR) of 11.5% during the forecast period of 2024-2030[5].

Market Segmentation

The cefoxitin market is segmented based on type, application, and geography. The Type I segment accounted for a noticeable share of the global market in 2023 and is expected to experience significant growth in the near future. The Application 1 segment is also expected to expand at a significant CAGR throughout the forecast period[2].

Key Players

The 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 focusing on strategies to strengthen their product portfolios and expand their business in the global market[5].

Regional Analysis

The cefoxitin market is classified geographically into North America, Europe, Asia Pacific, and the rest of the world. Each region presents unique market dynamics and growth opportunities, influenced by local healthcare needs, regulatory environments, and economic conditions[5].

Market Projections

Forecasted Growth

The cefoxitin market is anticipated to grow substantially due to several factors. The increasing incidence of bacterial infections, particularly those resistant to conventional antibiotics, drives the demand for effective antimicrobial agents like cefoxitin. Additionally, advancements in healthcare infrastructure and the adoption of updated clinical guidelines recommending cefoxitin as a first-line treatment are expected to boost market growth[2][5].

Technological and Regulatory Trends

Technological advancements, such as the use of AI in healthcare for personalized treatment plans, and regulatory updates supporting the use of cefoxitin in various clinical settings, will also contribute to the market's expansion. Local institutional guidelines, like those updated in June 2023 to recommend cefoxitin monotherapy for intra-amniotic infections and endometritis, play a crucial role in shaping market trends[4].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as the potential for antibiotic resistance and the need for continuous monitoring of adverse effects. However, these challenges also present opportunities for research and development, particularly in creating new formulations and combination therapies that enhance the efficacy and safety of cefoxitin[1][3].

Key Takeaways

• Clinical Efficacy: Cefoxitin has demonstrated strong efficacy in treating aerobic and anaerobic infections, including those caused by bacteria resistant to other antibiotics.
• Market Growth: The global cefoxitin market is projected to grow significantly, driven by increasing demand for effective antimicrobial agents and updated clinical guidelines.
• Key Players: Major pharmaceutical companies are investing in strategies to expand their market share and strengthen their product portfolios.
• Regional Dynamics: The market is influenced by regional healthcare needs, regulatory environments, and economic conditions.
• Future Trends: Technological advancements and regulatory updates are expected to continue driving market growth.

FAQs

What is cefoxitin used for?

Cefoxitin is used to treat a variety of bacterial infections, including those caused by aerobic and anaerobic bacteria. It is particularly effective against infections caused by bacteria resistant to other antibiotics.

What are the common side effects of cefoxitin?

Common side effects include drug eruptions, asymptomatic serum transaminase elevation, leukopenia, eosinophilia, and severe thrombophlebitis.

How is the global cefoxitin market projected to grow?

The global cefoxitin market is expected to grow from USD 100 million in 2023 to USD 250 million by 2030, with a CAGR of 11.5% during the forecast period.

Who are the key players in the cefoxitin market?

Key players include Apotex, Fresenius Kabi, Hikma, Sagent, WG Critical Care, B Braun, Teva, Pfizer, Shenzhen Zhijun Pharmaceutical, Luoxin Group, Lijian Pharma, and Qilu Pharmaceutical.

What are the main drivers of the cefoxitin market growth?

The main drivers include the increasing incidence of bacterial infections, advancements in healthcare infrastructure, and the adoption of updated clinical guidelines recommending cefoxitin as a first-line treatment.

Sources

1. Results of a clinical trial of cefoxitin, a new cephamycin antibiotic. PubMed.
2. Global Cefoxitin Market Report 2024 Edition. Cognitive Market Research.
3. Cefoxitin therapy of anaerobic and aerobic infections. Journal of Antimicrobial Chemotherapy.
4. Cefoxitin for Intra-amniotic Infections and Endometritis: A Retrospective Cohort Study. Clinical Infectious Diseases.
5. Cefoxitin Sodium Injection Market Size, Share, Growth | Global Forecast 2024-2030. Verified Market Reports.