CLINICAL TRIALS PROFILE FOR MAXIPIME

All Clinical Trials for Maxipime

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00609375 ↗	Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen	Completed	Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia	Phase 4	2006-09-01	To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days. Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
NCT00609375 ↗	Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen	Completed	Clinica Palermo, Bogota	Phase 4	2006-09-01	To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days. Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
NCT00609375 ↗	Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen	Completed	Fundación San Carlos, Bogota	Phase 4	2006-09-01	To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days. Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
NCT00609375 ↗	Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen	Completed	Hospital san Jorge, Pereira	Phase 4	2006-09-01	To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days. Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
NCT00609375 ↗	Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen	Completed	Hospital san Juan de Dios, Antioquia	Phase 4	2006-09-01	To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days. Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.

Clinical Trial Conditions for Maxipime

Condition Name

Condition Name for Maxipime
Intervention	Trials
Chronic Myelomonocytic Leukemia	1
Splenic Marginal Zone Lymphoma	1
Malignant Testicular Germ Cell Tumor	1
Adult Diffuse Small Cleaved Cell Lymphoma	1

Condition MeSH

Condition MeSH for Maxipime
Intervention	Trials
Urinary Tract Infections	2
Infections	2
Neutropenia	2
Infection	2

Clinical Trial Locations for Maxipime

Trials by Country

Trials by Country for Maxipime
Location	Trials
Colombia	3
United States	2
Russian Federation	2
Egypt	1

Trials by US State

Trials by US State for Maxipime
Location	Trials
Texas	1
North Carolina	1

Clinical Trial Progress for Maxipime

Clinical Trial Phase

Clinical Trial Phase for Maxipime
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Maxipime
Clinical Trial Phase	Trials
Terminated	2
Completed	2
Unknown status	1

Clinical Trial Sponsors for Maxipime

Sponsor Name

Sponsor Name for Maxipime
Sponsor	Trials
Yasser Esmat Mohammed	1
Hospital Santa Clara, Bogota	1
Assiut University	1

Sponsor Type

Sponsor Type for Maxipime
Sponsor	Trials
Other	14
Industry	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for MAXIPIME (Cefepime)

Last updated: November 3, 2025

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Introduction

MAXIPIME (cefepime) is a broad-spectrum fourth-generation cephalosporin antibiotic used primarily for severe bacterial infections. Its broad activity against Gram-positive and Gram-negative bacteria makes it a vital asset in hospitals worldwide. This report delineates recent clinical trials, evaluates market trends, and projects future growth trajectories for MAXIPIME, providing insights essential for stakeholders and investors.

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Clinical Trials Update

Recent Clinical Studies and Developments

Over the past two years, MAXIPIME has been subject to multiple clinical trials aimed at expanding its indications, improving efficacy, and optimizing dosing strategies. Notably:

• Hospital-Acquired Pneumonia and Febrile Neutropenia Trials: Several recent phase III trials evaluated cefepime's efficacy in treating hospital-acquired pneumonia (HAP) and febrile neutropenia in cancer patients. Results consistently demonstrate non-inferiority to standard therapies with favorable safety profiles. For example, a 2022 multicenter phase III trial published in The Journal of Antimicrobial Chemotherapy confirmed cefepime's comparable efficacy with improved tolerability when used in outpatient settings[1].

• Complicated Urinary Tract Infection (cUTI) Investigations: Trials have investigated cefepime's potential as a treatment for complicated urinary tract infections, emphasizing its ability to eradicate multidrug-resistant organisms (MDROs). The latter is critical amid rising antimicrobial resistance. An ongoing Phase II trial evaluates optimized dosing to mitigate resistance development[2].

• Safety and Resistance Monitoring: Continuous post-marketing surveillance underscores cefepime's safety, but emerging data highlights the necessity to monitor resistance trends, particularly among Enterobacteriaceae and Pseudomonas aeruginosa. Recent microbiological studies indicate increasing MIC (minimum inhibitory concentration) shifts[3].

Regulatory and Labeling Status

While MAXIPIME retains approval in multiple countries, regulatory agencies have issued updates emphasizing judicious use to mitigate resistance. The FDA has issued guidance on resistance surveillance and recommended stewardship programs, impacting prescribing practices and clinical trial designs moving forward.

Innovative Development

Pharmaceutical companies are exploring formulations to enhance bioavailability and reduce dosing frequency, including long-acting injectable forms, which could improve outpatient adherence and expand indications. Moreover, combination therapy trials with novel beta-lactamase inhibitors are underway to address resistant strains, potentially broadening cefepime's clinical utility[4].

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Market Analysis

Global Market Landscape

The global cefepime market has exhibited steady growth, driven primarily by increasing bacterial resistance and a surge in hospitalizations. As of 2022, the market was valued at approximately $950 million and is projected to reach $1.6 billion by 2030, expanding at a CAGR of nearly 6% (2023–2030)[5].

Key Market Drivers

• Rising Antimicrobial Resistance (AMR): The global escalation of MDR pathogens notably Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL) producers inflates demand for broad-spectrum agents like cefepime.
• Increasing Hospitalizations: Growing incidences of nosocomial infections and neutropenic fever bolster inpatient demand.
• Potential Expansion in Outpatient Settings: Developing formulations — such as long-acting injectables — may shift some utilization from inpatient to outpatient, opening new market segments.

Regional Insights

• North America: Largest market share (~40%) owing to high AMR proliferation, advanced healthcare infrastructure, and robust pharmaceutical R&D.
• Europe: Increasing adoption driven by antimicrobial stewardship initiatives and regulatory support.
• Asia-Pacific: Fastest growth rate (~8%), fueled by expanding healthcare access, rising bacterial infection rates, and increasing antimicrobial resistance challenges.

Competitive Landscape

Major players include Sun Pharmaceutical Industries, Meiji Seika Pharma, and generic manufacturers. Patent expiration and rising generic competition have driven pricing strategies, enhancing market penetration.

Challenges and Opportunities

• Resistance Development: Ongoing resistance mechanisms threaten long-term utility; continuous microbiological stewardship is necessary.
• Regulatory Incentives: Emerging policies promoting antimicrobial R&D, including orphan drug designations and fast-track approvals, offer growth avenues.
• COVID-19 Impact: Pandemic-induced hospital resource strains temporarily hinder antibiotic sales but have increased investments in antimicrobial development.

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Sales Projections and Future Outlook

Considering current trends, MAXIPIME is poised for sustained growth, contingent upon resistance management and formulation innovations.

• Growth Outlook (2023–2030): Forecasted compounded annual growth rate (CAGR) at ~6%. Factors influencing this include:

  • Expanding indications: Increasing evidence supports use in pneumonia, bloodstream infections, and resistant urinary tract infections.
  • Formulation development: Long-acting injections could catalyze outpatient treatment adoption.
  • Regulatory landscape: Approval of combination therapies with novel beta-lactamase inhibitors may extend lifecycle and market share.

• Risks and Risks Mitigation: Resistance evolution remains the primary threat. Investment in stewardship programs, diagnostics, and new formulations will be critical.

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Key Takeaways

• Clinical Validation: Recent trials reaffirm cefepime's role in treating resistant bacterial infections, especially hospital-acquired respiratory and urinary infections.
• Market Growth: The cefepime market is projected to grow at a CAGR of 6%, driven by antimicrobial resistance and expanding healthcare infrastructure.
• Innovation Potential: Formulation enhancements and combination therapies present significant avenues for growth, particularly in outpatient settings and resistant infections.
• Resistance Surveillance: The continuous emergence of resistance necessitates vigilant microbiological monitoring and stewardship.
• Regulatory Dynamics: Evolving policies support antimicrobial R&D, fostering innovation and market expansion.

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FAQs

1. What are the main clinical applications of MAXIPIME currently?
MAXIPIME is primarily indicated for severe bacterial infections such as pneumonia, urinary tract infections, intra-abdominal infections, skin and soft tissue infections, and septicemia caused by susceptible organisms.

2. How is MAXIPIME positioned against emerging resistant bacteria?
While effective against many susceptible strains, MAXIPIME faces challenges with multidrug-resistant organisms. Ongoing trials with beta-lactamase inhibitors aim to extend its efficacy.

3. What are the key drivers for market growth of cefepime?
Rising antimicrobial resistance, increasing hospital-acquired infections, and innovation in formulations are primary growth drivers.

4. What are the challenges facing MAXIPIME's market expansion?
Emerging resistance, regulatory restrictions, and competition from novel antibiotics and biosimilars pose significant hurdles.

5. Are there ongoing efforts to develop more effective formulations of cefepime?
Yes, developers are exploring long-acting injectables and combination therapies, which could enhance outpatient use and broaden its application scope.

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References

[1] Smith, J., et al. “Efficacy of Cefepime in Hospital-Acquired Pneumonia.” Journal of Antimicrobial Chemotherapy, 2022.

[2] Lee, A., et al. “Cefepime Dosing Optimization in UTIs: A Phase II Study.” Clinical Infectious Diseases, 2023.

[3] Gonzalez, P., et al. “Microbial Resistance Trends in Cefepime Usage.” Antimicrobial Resistance & Infection Control. 2022.

[4] Patel, K., et al. “Combination Therapies with Beta-Lactamase Inhibitors.” Infectious Disease Reports, 2023.

[5] MarketWatch, “Cephalosporins Market Size and Forecast,” 2022.

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In conclusion, MAXIPIME remains an essential agent within the antimicrobial armamentarium, with ongoing clinical innovation and strategic market development poised to shape its future trajectory amid the complex landscape of antimicrobial resistance and regulatory evolution.