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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR ROCEPHIN


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All Clinical Trials for Rocephin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00035347 ↗ Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia Completed Pfizer Phase 4 2001-01-01 A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
NCT00037479 ↗ Brain Imaging and Retreatment Study of Persistent Lyme Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 1999-12-01 The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.
NCT00538694 ↗ Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Completed Cubist Pharmaceuticals LLC Phase 3 2000-10-31 To evaluate the safety and efficacy of daptomycin in adults who have pneumonia due to Streptococcus pneumoniae.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rocephin

Condition Name

Condition Name for Rocephin
Intervention Trials
Pneumonia, Bacterial 2
Lyme Neuroborreliosis 1
Vertebral Osteomyelitis 1
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Condition MeSH

Condition MeSH for Rocephin
Intervention Trials
Pneumonia 3
Infections 3
Infection 3
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Clinical Trial Locations for Rocephin

Trials by Country

Trials by Country for Rocephin
Location Trials
United States 21
Japan 15
Canada 6
Taiwan 3
France 2
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Trials by US State

Trials by US State for Rocephin
Location Trials
Pennsylvania 2
Ohio 2
New York 2
Michigan 2
California 2
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Clinical Trial Progress for Rocephin

Clinical Trial Phase

Clinical Trial Phase for Rocephin
Clinical Trial Phase Trials
Phase 4 8
Phase 3 4
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Rocephin
Clinical Trial Phase Trials
Completed 9
Unknown status 4
Recruiting 3
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Clinical Trial Sponsors for Rocephin

Sponsor Name

Sponsor Name for Rocephin
Sponsor Trials
Pfizer 3
Cubist Pharmaceuticals LLC 2
KEMRI Wellcome Trust Research Program, Kenya 1
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Sponsor Type

Sponsor Type for Rocephin
Sponsor Trials
Other 35
Industry 7
NIH 2
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Rocephin (Ceftriaxone): Clinical Trials, Market Analysis, and Projections

Introduction to Rocephin

Rocephin, also known as ceftriaxone, is a third-generation cephalosporin antibiotic characterized by its high intrinsic activity, resistance to beta-lactamases, and a prolonged half-life of 8 hours, which is significantly longer than other cephalosporins[1].

Clinical Trials and Efficacy

Historical Clinical Studies

In early clinical studies, Rocephin was administered intravenously at a dosage of 2 x 1 g/day to 23 patients with septicaemia confirmed by positive blood cultures. The results were highly favorable, with 21 cases showing complete cure of the infection episode, one case requiring supplementation with ampicillin, and one poor outcome due to infection by resistant enterococci. The clinical and biological tolerance of Rocephin was excellent, and its administration was found to be particularly easy[1].

Comparative Studies

Recent studies have compared Rocephin with other antibiotic regimens. For instance, the EAGLE-1 phase III trial conducted by GSK compared the efficacy of gepotidacin, a new oral antibiotic, with the combination of intramuscular ceftriaxone and oral azithromycin for treating uncomplicated urogenital gonorrhoea. The trial demonstrated that gepotidacin was non-inferior to the ceftriaxone plus azithromycin combination, highlighting the ongoing relevance and effectiveness of ceftriaxone in treating bacterial infections[5].

Market Analysis

Current Market Size and Growth

The global ceftriaxone market is projected to grow significantly over the next few years. As of 2023, the market is valued at approximately $1.79 billion and is expected to reach $2.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 2.9% from 2022 to 2031[2].

Driving Factors

The increasing prevalence of bacterial infections is a major driver for the demand of ceftriaxone. Its broad-spectrum efficacy against various bacterial pathogens makes it a versatile treatment option for a range of infections, including urinary tract infections, intra-abdominal infections, endocarditis, acute bacterial otitis media, meningitis, and pneumonia[2].

Regional Market Performance

  • North America: This region is expected to be highly lucrative for the ceftriaxone market due to increasing healthcare expenditure and the early adoption of advanced technologies. Favorable funding for healthcare research also contributes to the strong demand for antibiotics like ceftriaxone in hospital settings[2].
  • Asia Pacific: This region is anticipated to dominate the ceftriaxone market during the forecast period. The growing healthcare infrastructure and a large patient base in countries such as India and China are key factors driving the market demand in this region[2].

Distribution Channels

The distribution of ceftriaxone is primarily through:

  • Hospital Pharmacies: Given its common use in hospital settings for treating severe infections.
  • Retail Pharmacies: For outpatient treatments and less severe infections.
  • Online Pharmacies: Increasingly popular for convenience and accessibility[2].

Indications and Uses

Ceftriaxone is indicated for a wide range of bacterial infections, including:

  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Endocarditis
  • Acute Bacterial Otitis Media
  • Meningitis
  • Pneumonia
  • Other Infections[2].

Competitive Landscape

The market for ceftriaxone is competitive, with several pharmaceutical companies involved in its production and distribution. The introduction of new antibiotics, such as gepotidacin, also impacts the competitive landscape, although ceftriaxone remains a staple due to its proven efficacy and broad spectrum of activity[5].

Future Projections and Challenges

Market Growth Projections

The ceftriaxone market is expected to continue growing, driven by the increasing need for effective antibiotics against bacterial infections. The projected CAGR of 2.9% from 2022 to 2031 indicates a steady and significant growth trajectory[2].

Challenges and Opportunities

One of the major challenges facing the ceftriaxone market is the rising resistance to antibiotics. This necessitates continuous research and development of new antibiotics and dosing regimens to maintain efficacy. For example, studies focused on optimizing dosing regimens for critically ill patients can improve clinical outcomes and address the issue of antibiotic resistance[4].

Key Takeaways

  • Clinical Efficacy: Rocephin has shown high efficacy in treating a wide range of bacterial infections.
  • Market Growth: The global ceftriaxone market is projected to reach $2.2 billion by 2031, growing at a CAGR of 2.9%.
  • Regional Performance: North America and Asia Pacific are key regions driving the market demand.
  • Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies are the primary distribution channels.
  • Indications: Ceftriaxone is used for various infections, including urinary tract infections, intra-abdominal infections, and meningitis.
  • Challenges: Rising antibiotic resistance is a significant challenge that requires ongoing research and development.

FAQs

Q: What is Rocephin (ceftriaxone), and how is it characterized?

A: Rocephin, or ceftriaxone, is a third-generation cephalosporin antibiotic known for its high intrinsic activity, resistance to beta-lactamases, and a prolonged half-life of 8 hours[1].

Q: What are the common indications for ceftriaxone?

A: Ceftriaxone is indicated for treating various bacterial infections, including urinary tract infections, intra-abdominal infections, endocarditis, acute bacterial otitis media, meningitis, and pneumonia[2].

Q: What is the projected market size of ceftriaxone by 2031?

A: The global ceftriaxone market is expected to reach $2.2 billion by 2031, growing at a CAGR of 2.9% from 2022 to 2031[2].

Q: Which regions are expected to dominate the ceftriaxone market?

A: North America and Asia Pacific are anticipated to be the most lucrative regions for the ceftriaxone market due to increasing healthcare expenditure and growing healthcare infrastructure, respectively[2].

Q: What are the primary distribution channels for ceftriaxone?

A: The primary distribution channels for ceftriaxone include hospital pharmacies, retail pharmacies, and online pharmacies[2].

Sources

  1. Clinical study of Rocephin, a 3d generation cephalosporin ... - PubMed
  2. Ceftriaxone Market Size Worth USD 2.2 billion by 2031, Expanding at a CAGR of 2.9% - GlobeNewswire
  3. Rocephin Drug Insight Report 2019 with Sales Forecasting to 2021 - Business Wire
  4. Office of Infectious Diseases Research Overview - FDA
  5. GSK announces positive headline results from EAGLE-1 phase III trial for gepotidacin - GSK

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