CLINICAL TRIALS PROFILE FOR MEFOXIN

All Clinical Trials for MEFOXIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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 MEFOXIN

Condition Name

Condition Name for MEFOXIN
Intervention	Trials
Puerperal Sepsis	1

Condition MeSH

Condition MeSH for MEFOXIN
Intervention	Trials
Sepsis	1
HIV Seropositivity	1

Clinical Trial Locations for MEFOXIN

Trials by Country

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−

Trials by Country for MEFOXIN
Location	Trials
South Africa	1

Clinical Trial Progress for MEFOXIN

Clinical Trial Phase

Clinical Trial Phase for MEFOXIN
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for MEFOXIN
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for MEFOXIN

Sponsor Name

Sponsor Name for MEFOXIN
Sponsor	Trials
Bristol-Myers Squibb	1
University of KwaZulu	1

Sponsor Type

Sponsor Type for MEFOXIN
Sponsor	Trials
Other	1
Industry	1

Mefoxin: Clinical Trials, Market Analysis, and Projections

Introduction to Mefoxin

Mefoxin, also known as cefoxitin, is a second-generation cephamycin antibiotic that is widely used to treat various bacterial infections. It is particularly effective against Gram-negative bacteria and is often used in surgical prophylaxis and the treatment of intra-abdominal infections.

Clinical Trials and Efficacy

Comparative Studies with Other Antimicrobials

Recent clinical trials have compared the efficacy of Mefoxin with other antimicrobial agents. A phase 3 randomized clinical trial compared Mefoxin (cefoxitin) with piperacillin-tazobactam in the context of perioperative antimicrobial prophylaxis. The trial found that patients treated with piperacillin-tazobactam had lower rates of surgical site infections (SSIs) and postoperative sepsis compared to those treated with cefoxitin. However, the trial was terminated early due to the predefined stopping rule being met, indicating significant differences in outcomes[1].

Treatment of Intra-Amniotic Infections

Another study published in Clinical Infectious Diseases evaluated the use of Mefoxin monotherapy versus traditional antimicrobial therapy for intra-amniotic infections (IAI) and endometritis. The study found that Mefoxin monotherapy was noninferior to traditional therapy in preventing severe clinical events after delivery. Patients receiving Mefoxin had lower odds of experiencing severe clinical events and hospital readmission for IAI or endometritis[4].

Market Analysis

Global Market Overview

The global Mefoxin market is expected to grow over the forecast period, driven by increasing demand for effective antimicrobial treatments. The market is segmented by product, application, end-users, and geography. Key players in the market include Merck KGaA, GSK, CJ CheilJedang, Chong Kun Dang, Astellas, and Sandoz[2].

Market Segmentation

• Product Segmentation: The market is segmented into different product concentrations, such as 0.98 and 0.9 g formulations.
• Application Segmentation: Mefoxin is used to treat a variety of infections, including those caused by Haemophilus influenzae, Neisseria gonorrhoeae, Lyme disease, and others[2].

Drivers and Restraints

The growth of the Mefoxin market is driven by several factors, including the increasing prevalence of bacterial infections, advancements in healthcare infrastructure, and regulatory reforms. However, the market also faces restraints such as evolving lifestyles, taxation policies, and purchasing power variations across different economies[2].

Competitive Landscape

The competitive landscape of the Mefoxin market is characterized by strategic initiatives taken by key players. These include research and development activities, expansion plans, and financial outlooks. Companies like Merck and GSK are investing heavily in R&D to enhance their market share[2].

Market Projections

Forecast Period

The global Mefoxin market is forecasted to grow significantly from 2025 to 2031. The market size, revenue, and volume share are expected to increase, driven by the growing demand for antimicrobial treatments. The base year for these calculations is 2023, with historical data from 2019 to 2023 and forecasted data from 2025 to 2031[5].

Regional Analysis

The market is geographically segmented, with the Asia Pacific region expected to show significant growth. Factors such as changing demographics, regulatory reforms, and increasing healthcare investments are driving this growth[2].

SWOT and Porter's Five Forces Analysis

Market research reports include detailed SWOT and Porter's five forces analyses to provide a comprehensive view of the market. These analyses help identify the strengths, weaknesses, opportunities, and threats in the market, as well as the competitive forces that shape the industry[2][5].

Key Players and Their Strategies

Major Manufacturers

Key players in the Mefoxin market include Merck KGaA, GSK, CJ CheilJedang, Chong Kun Dang, Astellas, and Sandoz. These companies are focusing on research and development, expanding their product portfolios, and enhancing their distribution networks to maintain market dominance[2].

Financial Outlook and Expansion Plans

Companies are investing in R&D to develop new formulations and applications of Mefoxin. For example, Merck and GSK are expanding their manufacturing activities and exploring new markets to increase their market share[2].

Regulatory and Safety Considerations

Clinical Trial Regulations

Clinical trials involving Mefoxin are subject to stringent regulatory guidelines. For instance, the phase 3 trial comparing Mefoxin with piperacillin-tazobactam was monitored by an independent data and safety monitoring board (DSMB) to ensure ethical conduct and safety[1].

Safety Profile

Studies have shown that Mefoxin has a favorable safety profile. The retrospective observational cohort study on intra-amniotic infections found no significant safety concerns with Mefoxin monotherapy, including no deaths or deep surgical site infections reported during the study period[4].

Market Trends and Opportunities

Increasing Demand for Antimicrobials

The increasing prevalence of bacterial infections and the rise of antibiotic-resistant strains are driving the demand for effective antimicrobials like Mefoxin. This trend is expected to continue, providing opportunities for market growth[3].

Technological Advancements

Advancements in healthcare technology and pharmaceutical manufacturing are expected to improve the efficacy and availability of Mefoxin. These advancements include better formulations and delivery systems that enhance patient compliance and treatment outcomes[5].

Challenges and Restraints

Antibiotic Resistance

One of the significant challenges facing the Mefoxin market is the growing issue of antibiotic resistance. As bacteria develop resistance to existing antibiotics, there is a need for continuous innovation and development of new antimicrobial agents[3].

Regulatory Hurdles

Regulatory changes and stringent approval processes can act as restraints to market growth. Companies must navigate complex regulatory environments to bring new products or formulations to the market[2].

Conclusion

Mefoxin remains a crucial antibiotic in the treatment of various bacterial infections. Clinical trials have demonstrated its efficacy, particularly in the context of intra-amniotic infections and surgical prophylaxis. The global market for Mefoxin is expected to grow, driven by increasing demand and advancements in healthcare.

Key Takeaways

• Efficacy in Clinical Trials: Mefoxin has shown noninferiority to traditional antimicrobial therapy in treating intra-amniotic infections.
• Market Growth: The global Mefoxin market is projected to grow significantly from 2025 to 2031.
• Key Players: Major manufacturers include Merck KGaA, GSK, CJ CheilJedang, and others.
• Regulatory Considerations: Clinical trials are subject to stringent regulatory guidelines to ensure safety and efficacy.
• Market Trends: Increasing demand for antimicrobials and technological advancements are driving market growth.

FAQs

What is Mefoxin used for?

Mefoxin (cefoxitin) is used to treat various bacterial infections, including intra-abdominal infections, surgical site infections, and infections caused by Gram-negative bacteria.

Which companies are major players in the Mefoxin market?

Major players in the Mefoxin market include Merck KGaA, GSK, CJ CheilJedang, Chong Kun Dang, Astellas, and Sandoz.

What are the key drivers of the Mefoxin market?

The key drivers include the increasing prevalence of bacterial infections, advancements in healthcare infrastructure, and regulatory reforms.

What are the restraints facing the Mefoxin market?

Restraints include evolving lifestyles, taxation policies, purchasing power variations, and the growing issue of antibiotic resistance.

What is the forecasted growth period for the Mefoxin market?

The market is forecasted to grow significantly from 2025 to 2031.

Sources

1. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy. JAMA Network.
2. Global Mefoxin Market Study 2022-2028. OpenPR.
3. Global Drug Forecast and Market Analysis to 2026. GlobalData.
4. Cefoxitin Noninferior to Traditional Antimicrobial Therapy for Intraamniotic Infections. Infectious Disease Advisor.
5. Mefoxin Market Report 2024 (Global Edition). Cognitive Market Research.