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.
NCT00609375 ↗	Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen	Completed	Hospital Santa Clara, 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.

Clinical Trial Conditions for Maxipime

Condition Name

Condition Name for Maxipime
Intervention	Trials
Febrile Neutropenia	1
Myelodysplastic/Myeloproliferative Neoplasms	1
Adult Acute Lymphoblastic Leukemia	1
Pseudomonas Aeruginosa	1

Condition MeSH

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

Clinical Trial Locations for Maxipime

Trials by Country

Trials by Country for Maxipime
Location	Trials
Colombia	3
Russian Federation	2
United States	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
Completed	2
Terminated	2
Recruiting	1

Clinical Trial Sponsors for Maxipime

Sponsor Name

Sponsor Name for Maxipime
Sponsor	Trials
Wake Forest University Health Sciences	1
Takeda	1
Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia	1

Sponsor Type

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

MAXIPIME: Clinical Trials, Market Analysis, and Projections

Introduction to MAXIPIME

MAXIPIME, also known as cefepime, is a fourth-generation cephalosporin antibiotic used to treat a variety of bacterial infections, including complicated urinary tract infections (cUTI) and lower respiratory tract infections. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

EXBLIFEP Clinical Trial

A significant clinical trial for a drug closely related to MAXIPIME is the EXBLIFEP trial. Although EXBLIFEP is not MAXIPIME itself, it provides valuable insights into the efficacy and safety profile of similar cephalosporins.

• Trial Design: The EXBLIFEP trial was a multinational, double-blind, noninferiority clinical trial involving 1,041 patients with cUTI, including pyelonephritis, conducted across 90 sites in 19 countries[1].
• Efficacy Results: The trial demonstrated that EXBLIFEP was noninferior to piperacillin/tazobactam, with a composite response rate of 79% in the EXBLIFEP group compared to 59% in the piperacillin/tazobactam group. Clinical cure and microbiological response rates were also favorable for EXBLIFEP[1].

Cefepime-Taniborbactam Trial

Another relevant trial is the Phase 3 study of cefepime-taniborbactam, an investigational combination drug.

• Trial Outcomes: This study showed that cefepime-taniborbactam met the primary noninferiority efficacy endpoint and demonstrated statistical superiority to meropenem in treating cUTI, including acute pyelonephritis. The combination drug had a composite microbiologic and clinical success rate of 70% compared to 58% for meropenem[4].

Market Analysis

Global Cefepime Market

The global cefepime market is experiencing significant growth driven by several factors.

• Market Size and Growth: As of 2023, the global cefepime market size was substantial, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented into regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[5].
• Segment Analysis: The intramuscular injection segment accounted for a noticeable share of the global cefepime market in 2023 and is expected to grow significantly. The lower respiratory tract infection segment is also expected to expand at a significant CAGR throughout the forecast period[5].

Key Players and Strategies

Major companies in the cefepime market are focusing on strengthening their product portfolios and expanding their business globally.

• Competitor Analysis: Companies like Baxter and B. Braun Medical are key players in the market, with strategies aimed at increasing market share and product offerings[5].
• Regional Analysis: North America, Europe, and Asia Pacific are significant regions for the cefepime market, with each region showing unique trends and growth opportunities. For instance, the Asia Pacific region is growing due to the constant advancements in clinical research and the ease of recruiting diverse patient populations[5].

Market Projections

Forecast Period

The forecast period for the cefepime market extends from 2025 to 2031, with several factors expected to drive growth.

• Growth Drivers: The increasing demand for effective antibiotics, advancements in clinical research, and the rising preference for personalized medicine are key drivers. The integration of omics technologies in clinical trials, as seen in other markets, is also expected to influence the cefepime market positively[3][5].
• Regional Growth: North America is expected to remain a dominant market, driven by the increasing preference for personalized medicine and the rising access to clinical trials. The Asia Pacific region is also anticipated to grow significantly due to its large and diverse patient population and advancements in clinical research[3][5].

Technological and Regulatory Trends

Omics-Based Clinical Trials

The integration of omics technologies (genomics, proteomics, metabolomics) in clinical trials is a significant trend that could impact the cefepime market.

• Market Growth: The global omics-based clinical trials market is projected to grow from USD 32.85 billion in 2024 to USD 70.92 billion by 2034, with a CAGR of 8.0%. This growth is driven by the increasing investment in personalized medicine and technological advancements[3].
• Regulatory Support: Regulatory bodies are increasingly supporting the integration of omics data in clinical trial research, which could enhance the efficacy and safety of drugs like cefepime[3].

Key Takeaways

• Clinical Efficacy: Recent clinical trials, such as those for EXBLIFEP and cefepime-taniborbactam, have demonstrated the efficacy and safety of cefepime-based treatments for cUTI and other infections.
• Market Growth: The global cefepime market is expected to grow significantly from 2025 to 2031, driven by increasing demand, advancements in clinical research, and the integration of omics technologies.
• Regional Trends: North America and the Asia Pacific region are expected to be key markets, with growth driven by different factors such as personalized medicine and diverse patient populations.
• Technological Advancements: The increasing use of omics technologies in clinical trials is expected to enhance the development and validation of cefepime and other antibiotics.

FAQs

What is MAXIPIME (cefepime), and how is it used?

MAXIPIME, or cefepime, is a fourth-generation cephalosporin antibiotic used to treat various bacterial infections, including complicated urinary tract infections and lower respiratory tract infections.

What were the outcomes of the EXBLIFEP clinical trial?

The EXBLIFEP trial demonstrated that the drug was noninferior to piperacillin/tazobactam in treating cUTI, with favorable clinical cure and microbiological response rates.

How does the cefepime-taniborbactam combination compare to other treatments?

The cefepime-taniborbactam combination showed statistical superiority to meropenem in treating cUTI, including acute pyelonephritis, with a higher composite microbiologic and clinical success rate.

What are the key drivers of the global cefepime market growth?

The key drivers include increasing demand for effective antibiotics, advancements in clinical research, and the rising preference for personalized medicine.

How is the integration of omics technologies impacting the cefepime market?

The integration of omics technologies in clinical trials is expected to enhance the efficacy and safety of cefepime by providing valuable insights into patient-specific responses at a molecular level.

Which regions are expected to dominate the cefepime market in the future?

North America and the Asia Pacific region are expected to be dominant markets, driven by factors such as personalized medicine and diverse patient populations.

Sources

1. FDA Drug Trials Snapshots: EXBLIFEP - FDA
2. Cefepime Injection Market Report 2024 - Cognitive Market Research
3. Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034 - BioSpace
4. Venatorx Pharmaceuticals Announces Positive Results for Phase 3 Clinical Trial of Cefepime-Taniborbactam - Venatorx Pharmaceuticals
5. Global Cefepime Market Report 2024 Edition - Cognitive Market Research

Last updated: 2025-01-01