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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR CEFTAROLINE FOSAMIL


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All Clinical Trials for Ceftaroline Fosamil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00633126 ↗ Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age Completed Forest Laboratories Phase 1 2008-03-01 The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
NCT00633152 ↗ Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections Completed Forest Laboratories Phase 2 2008-02-01 The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
NCT01281462 ↗ Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections Completed Forest Laboratories Phase 2 2010-12-01 This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.
NCT01290900 ↗ A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as Completed AstraZeneca Phase 1 2011-02-01 This is a single dose study in healthy male volunteers to investigate the effect of high doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval
NCT01290900 ↗ A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as Completed Pfizer Phase 1 2011-02-01 This is a single dose study in healthy male volunteers to investigate the effect of high doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval
NCT01298843 ↗ Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital Completed Forest Laboratories Phase 4 2011-04-01 The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
NCT01400867 ↗ Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections Completed AstraZeneca Phase 2/Phase 3 2011-12-01 This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ceftaroline Fosamil

Condition Name

Condition Name for Ceftaroline Fosamil
Intervention Trials
Infections 4
Complicated Skin and Soft Tissue Infection 2
Pneumonia 2
Healthy 2
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Condition MeSH

Condition MeSH for Ceftaroline Fosamil
Intervention Trials
Infections 9
Infection 9
Communicable Diseases 7
Pneumonia 6
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Clinical Trial Locations for Ceftaroline Fosamil

Trials by Country

Trials by Country for Ceftaroline Fosamil
Location Trials
United States 124
Spain 6
Poland 6
Greece 6
Romania 5
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Trials by US State

Trials by US State for Ceftaroline Fosamil
Location Trials
California 11
Ohio 10
Texas 9
Florida 8
Michigan 7
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Clinical Trial Progress for Ceftaroline Fosamil

Clinical Trial Phase

Clinical Trial Phase for Ceftaroline Fosamil
Clinical Trial Phase Trials
Phase 4 7
Phase 3 3
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ceftaroline Fosamil
Clinical Trial Phase Trials
Completed 22
Withdrawn 2
Terminated 2
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Clinical Trial Sponsors for Ceftaroline Fosamil

Sponsor Name

Sponsor Name for Ceftaroline Fosamil
Sponsor Trials
Forest Laboratories 20
AstraZeneca 12
Pfizer 9
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Sponsor Type

Sponsor Type for Ceftaroline Fosamil
Sponsor Trials
Industry 43
Other 12
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Ceftaroline Fosamil: Clinical Trials, Market Analysis, and Projections

Introduction

Ceftaroline fosamil, a broad-spectrum cephalosporin antibiotic, has been a significant player in the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs) since its approval by the US FDA in 2010. This article delves into the clinical trials, market analysis, and future projections for ceftaroline fosamil.

Clinical Trials Overview

Community-Acquired Bacterial Pneumonia (CABP)

The efficacy and safety of ceftaroline fosamil in treating CABP were evaluated in two large phase 3 programs: FOCUS 1 and FOCUS 2. These randomized, double-blind, multicenter trials compared ceftaroline fosamil with ceftriaxone. The results showed that ceftaroline fosamil was noninferior to ceftriaxone, with clinical cure rates in the ceftaroline group being numerically higher (84.3% vs 77.7%) in the clinically evaluable population[1][3].

Acute Bacterial Skin and Skin Structure Infections (ABSSSIs)

For ABSSSIs, ceftaroline fosamil was compared with vancomycin plus aztreonam in the CANVAS 1 and CANVAS 2 trials. These studies demonstrated that ceftaroline fosamil had similar microbiologically evaluable success rates to the comparator agents. Notably, ceftaroline fosamil showed high clinical cure rates in patients with methicillin-resistant Staphylococcus aureus (MRSA) infections, similar to those with methicillin-susceptible S. aureus infections[1].

Pediatric Clinical Trials

In pediatric populations, ceftaroline fosamil was evaluated in several randomized, active-controlled clinical trials for ABSSSIs and CABP. These studies, though not powered for statistical inferential testing, were designed to assess safety and extrapolate efficacy from adult data. The results indicated that ceftaroline fosamil was well-tolerated and had clinical response rates similar to those observed in adults across all age cohorts[4].

Safety and Tolerability

Ceftaroline fosamil has been shown to have a safety profile similar to that of its comparator agents in both adult and pediatric trials. The rates of adverse events, serious adverse events, deaths, and premature discontinuations due to adverse events were comparable between ceftaroline fosamil and the control groups[1][3][4].

Market Analysis

Current Market Size and Growth

The global ceftaroline fosamil market has seen significant growth since its introduction. As of 2023, the market size was substantial, and it is projected to continue growing at a compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by product, application, distribution channel, and region, providing a comprehensive view of the industry's dynamics[2].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region's revenue share, current trends, and future prospects are analyzed to provide a detailed understanding of the market's geographical distribution. The report includes figures, graphs, and tables to illustrate the data analysis at the country and regional levels[2].

Market Trends and Drivers

The growth of the ceftaroline fosamil market is driven by several factors, including the increasing incidence of bacterial infections, the rise in antibiotic resistance, and the need for effective broad-spectrum antibiotics. The market analysis also highlights opportunities such as expanding into new regions and the potential for increased demand due to emerging healthcare needs[2].

Competitive Analysis

The ceftaroline fosamil market is competitive, with several key players involved. The report provides a competitor analysis, assessing factors such as profit, product price, capacity, production, and supply-demand dynamics to create a clear picture of the market's competitive landscape[2].

Market Projections

Forecast Period

The market forecast extends from 2024 to 2031, with the base year being 2023. The report provides an in-depth analysis of the market size, revenue, and growth rate for each segment and region during this period. It also includes quantitative and qualitative analyses to understand the driving factors for the fastest-growing segments and their expected growth rates[2].

Future Market Opportunities

The ceftaroline fosamil market is expected to benefit from several future opportunities, including the increasing demand for antibiotics due to rising bacterial infections and the expansion into new markets. The report highlights segments that are expected to be most lucrative in the near future and their anticipated growth rates[2].

Clinical Outcomes and Economic Impact

Clinical Response and Resource Use

Studies have shown that ceftaroline fosamil is effective in treating adults with CAP, including severe CAP, in various regions such as Europe and Latin America. Clinical response to ceftaroline fosamil was associated with significant reductions in healthcare resource use, including shorter lengths of ICU stay and lower hospital costs compared to non-responders[5].

Economic Benefits

The use of ceftaroline fosamil can lead to substantial economic benefits by reducing healthcare resource utilization. For instance, a study found that clinical response to ceftaroline fosamil resulted in over 60% shorter lengths of ICU stay and over 30% lower hospital costs compared to non-responders[5].

Key Takeaways

  • Clinical Efficacy: Ceftaroline fosamil has demonstrated noninferiority to comparator agents in treating CABP and ABSSSIs, with high clinical cure rates.
  • Safety Profile: The drug has a safety profile similar to that of its comparator agents, making it a reliable option.
  • Market Growth: The global ceftaroline fosamil market is projected to grow at a significant CAGR from 2024 to 2031.
  • Regional Analysis: The market is segmented into major regions, each with its own growth prospects and trends.
  • Economic Impact: Ceftaroline fosamil can reduce healthcare resource use, leading to significant economic benefits.

FAQs

What is ceftaroline fosamil used for?

Ceftaroline fosamil is used for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs).

How effective is ceftaroline fosamil in treating CABP?

Ceftaroline fosamil has been shown to be noninferior to ceftriaxone in treating CABP, with numerically higher clinical cure rates in some studies[1][3].

Is ceftaroline fosamil safe for pediatric use?

Yes, ceftaroline fosamil has been evaluated in pediatric clinical trials and has been found to be well-tolerated and safe for use in children from 2 months to less than 18 years of age[4].

What is the projected growth rate of the ceftaroline fosamil market?

The global ceftaroline fosamil market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031, though the exact rate is not specified in the available sources[2].

How does ceftaroline fosamil impact healthcare resource use?

Ceftaroline fosamil can significantly reduce healthcare resource use by shortening ICU stays and lowering hospital costs compared to non-responders[5].

Sources

  1. Clinical Trial Studies: "Summary of Ceftaroline Fosamil Clinical Trial Studies and Clinical Experience" - Clinical Infectious Diseases[1].
  2. Market Report: "Ceftaroline Fosamil Market Report 2024 (Global Edition)" - Cognitive Market Research[2].
  3. Integrated Analysis: "Integrated Analysis of FOCUS 1 and FOCUS 2: Randomized, Double-Blind, Multicenter Trials of Ceftaroline Fosamil for the Treatment of Community-Acquired Pneumonia" - Clinical Infectious Diseases[3].
  4. Pediatric Clinical Trials: "Ceftaroline fosamil Clinical CD PREA" - FDA[4].
  5. Clinical Outcomes and Economic Impact: "Ceftaroline fosamil treatment patterns and outcomes in adults with community-acquired pneumonia" - Journal of Antimicrobial Chemotherapy[5].

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