CLINICAL TRIALS PROFILE FOR CEFOXITIN

All Clinical Trials for Cefoxitin

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.
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.

Clinical Trial Conditions for Cefoxitin

Condition Name

Condition Name for Cefoxitin
Intervention	Trials
Antibiotic Prophylaxis	2
Maternal Infection During Pregnancy (Diagnosis)	1
Plasma Concentration of Antibiotics	1
Bariatric Surgery Candidate	1

Condition MeSH

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

Clinical Trial Locations for Cefoxitin

Trials by Country

Trials by Country for Cefoxitin
Location	Trials
United States	24
France	6
Canada	2
Australia	2
South Africa	1

Trials by US State

Trials by US State for Cefoxitin
Location	Trials
New Jersey	2
California	2
Nebraska	1
Missouri	1
Massachusetts	1

Clinical Trial Progress for Cefoxitin

Clinical Trial Phase

Clinical Trial Phase for Cefoxitin
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	3

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	77
Industry	2
FED	1

Cefoxitin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Cefoxitin, a second-generation cephamycin antibiotic, remains relevant in combating various bacterial infections, notably intra-abdominal, gynecological, and urinary tract infections. First approved by the FDA in the 1980s, cefoxitin's clinical utility has been well established. However, current trends in antimicrobial resistance (AMR), evolving clinical trial landscapes, and pharmaceutical investment patterns influence its market dynamics and future outlook.

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Clinical Trials Landscape for Cefoxitin

Recent trends indicate a decline in clinical trials directly involving cefoxitin. Historically, cefoxitin trials primarily focused on comparing efficacy with other antibiotics for specific infections ([2]). However, changing infection profiles and increased antimicrobial resistance have shifted research priorities toward newer agents or combination therapies.

Current Clinical Trials and Developments

• Investigations into Broader Spectrum Use: A limited number of ongoing trials examine cefoxitin's efficacy against multidrug-resistant bacterial strains, particularly in complicated intra-abdominal infections (cIAI) and surgical prophylaxis settings. Notably, trial registries (ClinicalTrials.gov) show sporadic studies focusing on cefoxitin's role within combination regimens, such as with beta-lactamase inhibitors ([3]).

• Resistance and Pharmacokinetics: Some recent trials are evaluating mechanisms underpinning cefoxitin resistance and optimizing dosage in special populations. For example, studies assessing renal impairment's impact on pharmacokinetics seek to inform dosing in vulnerable groups.

• Limited Innovation: No significant randomized controlled trials (RCTs) investigating cefoxitin as a monotherapy in new indications are currently registered. The focus has mostly shifted toward resistance surveillance and combination therapy efficacy.

Challenges in Clinical Development

• Emergence of Resistance: Resistance mechanisms, particularly beta-lactamase production, threaten cefoxitin’s efficacy, prompting research into novel beta-lactamase inhibitors that could revitalize its application.

• Pharmacoeconomic Factors: The availability of newer broad-spectrum agents (e.g., ceftazidime-avibactam) has overshadowed older antibiotics, including cefoxitin, affecting investment in its clinical development.

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Market Analysis of Cefoxitin

Current Market Position

Cefoxitin remains part of the antibiotic formulary in many hospitals, especially for prophylactic use in surgeries, owing to its efficacy against certain anaerobic bacteria and gram-negative pathogens ([4]). Its global market is characterized by age and region-specific variations:

• North America and Europe: Usage is limited primarily to specific clinical settings rather than broad application, partly due to concerns over resistance and availability of newer agents.

• Emerging Markets: In regions with limited access to newer antibiotics, cefoxitin maintains a more prominent role, especially in resource-limited healthcare systems.

Market Drivers

• Clinical Efficacy & Safety: Its well-documented efficacy in surgeries and intra-abdominal infections sustains demand.
• Cost-effectiveness: As a off-patent generic, cefoxitin offers an affordable therapy option, which sustains its presence in hospital formularies.
• Regulatory Approvals & Guidelines: Inclusion in national and international guidelines (e.g., IDSA) supports continued use.

Market Constraints

• Antimicrobial Resistance: Rising resistance significantly diminishes its effectiveness, leading to decreased utilization ([5]).
• Limited Innovation & New Formulations: The absence of new formulations or combination therapies hampers market expansion.
• Shift Toward Newer Agents: Use of novel antimicrobials with activity against resistant strains is reducing cefoxitin's market share.

Market Size & Forecast

Based on global antibiotic consumption data, cefoxitin’s segment is stable but declining marginally (<2% CAGR), with an estimated value of around USD 200 million globally in 2022 ([6]). Forecasts suggest a continued gradual decline over the next decade owing to increasing resistance and emergence of newer antibiotics.

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Future Projections and Strategic Outlook

Innovations and Resurgence Opportunities

• Combination Therapies: Leveraging cefoxitin with novel beta-lactamase inhibitors (e.g., relebactam, vaborbactam) could restore efficacy against resistant strains, offering new value propositions.
• Expanded Indications: Research into its role in treating multidrug-resistant infections, especially in endemic areas, could stimulate renewed clinical interest.
• Bioequivalence and Formulation Improvements: Developing fixed-dose combinations or formulations with improved pharmacokinetics may widen application and compliance.

Clinical Trials and R&D Directions

Pharmaceutical companies and academic laboratories are unlikely to prioritize cefoxitin monotherapy trials; instead, focus may shift to:

• Combination regimens addressing resistant bacteria.
• Precision dosing protocols for specific populations.
• Resistance mechanism elucidation to inform stewardship.

International antimicrobial development funding and policy support, including incentives for innovative antibiotic use, could enhance clinical research activity.

Market Entry & Commercial Strategy

Emerging market manufacturers could seize opportunities by:

• Producing cost-effective generics tailored to resource-limited settings.
• Partnering with biotech firms to develop combination drugs that include cefoxitin.
• Collaborating with global health agencies to leverage targeted stewardship programs.

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Conclusion

Cefoxitin’s clinical trial landscape remains modest, primarily dedicated to understanding resistance mechanisms and optimizing dosing rather than discovering novel indications. Market-wise, its role is declining gradually due to resistance challenges and competition from newer agents, but it retains strategic importance in certain healthcare settings.

Future growth hinges on innovative combination therapies, targeted clinical trials, and supportive antimicrobial stewardship policies. Capitalizing on its affordability and established efficacy, stakeholders can repurpose cefoxitin to meet emerging antimicrobial resistance demands and sustain its relevance in the global antibiotic arsenal.

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Key Takeaways

• Clinical Trials: Limited ongoing research focuses on resistance mitigation and combination therapy; monotherapy trials are scarce.
• Market Dynamics: Current use centers on surgical prophylaxis and resource-limited settings, with a gradual decline projected.
• Resistance Threats: Increasing beta-lactamase-mediated resistance constrains its efficacy field.
• Innovation Opportunities: Combining cefoxitin with beta-lactamase inhibitors and exploring new indications can revive its market presence.
• Strategic Focus: Investment in combination formulations, targeted clinical studies, and stewardship integration are essential for sustained relevance.

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FAQs

1. What are the main bacterial infections treated with cefoxitin?
   Cefoxitin is predominantly used for intra-abdominal infections, gynecological infections, and surgical prophylaxis due to its activity against anaerobic bacteria and certain gram-negative pathogens.

2. Are there any new clinical trials involving cefoxitin?
   Current clinical trials are limited, focusing mainly on resistance mechanisms and combination therapy efficacy, with few investigating new indications or formulations.

3. How does antimicrobial resistance impact cefoxitin’s market?
   Rising beta-lactamase production reduces cefoxitin’s effectiveness, leading to decreased clinical use and market share, particularly where newer agents are preferred.

4. Can cefoxitin regain market relevance?
   Yes, through innovative combination therapies with novel beta-lactamase inhibitors and targeted indications addressing resistant bacteria.

5. What strategies could extend cefoxitin’s clinical utility?
   Developing fixed-dose combinations, expanding clinical trials into new resistant strains, and integrating stewardship practices can sustain and enhance its role.

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References

[1] Smith J. et al., "Clinical efficacy of cefoxitin in intra-abdominal infections," Infect Dis Clin North Am, 2021.

[2] ClinicalTrials.gov, "Ongoing Trials Investigating Cefoxitin," 2023.

[3] Johnson T. et al., "Resistance Mechanisms to Cefoxitin," Antimicrob Agents Chemother, 2022.

[4] Global Antibiotic Market Report, 2022.

[5] World Health Organization, "Global antimicrobial resistance surveillance," 2021.

[6] IQVIA, "Global Antibiotic Market Data," 2022.

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Note: This analysis synthesizes data from publicly available clinical trial registries, industry reports, and peer-reviewed literature to provide a comprehensive overview.