CLINICAL TRIALS PROFILE FOR CEFACLOR

All Clinical Trials for cefaclor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	James Graham Brown Cancer Center	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	University of Louisville	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	Julio Ramirez	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT00084201 ↗	Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections	Completed	National Center for Complementary and Integrative Health (NCCIH)	N/A	2006-07-01	The purpose of study is to determine whether cranberry juice interacts with antibiotics used to treat urinary tract infections (UTIs).
NCT00257140 ↗	A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 2/Phase 3	1931-06-01	The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.
NCT00257140 ↗	A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 2/Phase 3	1931-06-01	The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

Clinical Trial Conditions for cefaclor

Condition Name

Condition Name for cefaclor
Intervention	Trials
Bronchitis	1
Bronchitis, Chronic	1
Endocarditis Infective	1
Osteomyelitis	1

Condition MeSH

Condition MeSH for cefaclor
Intervention	Trials
Acute Disease	1
Urinary Tract Infections	1
Endocarditis, Bacterial	1
Infections	1

Clinical Trial Locations for cefaclor

Trials by Country

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−

Trials by Country for cefaclor
Location	Trials
United States	2
Spain	1

Trials by US State

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−

Trials by US State for cefaclor
Location	Trials
Kentucky	1
Washington	1

Clinical Trial Progress for cefaclor

Clinical Trial Phase

Clinical Trial Phase for cefaclor
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for cefaclor
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for cefaclor

Sponsor Name

Sponsor Name for cefaclor
Sponsor	Trials
Julio Ramirez	1
Fundacion Clinic per a la Recerca Biomédica	1
National Center for Complementary and Integrative Health (NCCIH)	1

Sponsor Type

Sponsor Type for cefaclor
Sponsor	Trials
Other	4
Industry	2
NIH	1

Cefaclor: Clinical Trials, Market Analysis, and Projections

Introduction to Cefaclor

Cefaclor is a small molecule antibiotic belonging to the cephalosporin class, primarily targeting penicillin-binding proteins (PBPs) to exert its therapeutic effects. Developed by Eli Lilly & Co., it has been approved for use in various therapeutic areas, including infectious diseases, respiratory diseases, and skin and musculoskeletal diseases, among others[1].

Clinical Trials and Development Status

Cefaclor has successfully completed the highest phase of clinical trials and has been approved globally. This extensive testing and evaluation have solidified its position as a reliable treatment for a range of bacterial infections. The drug's efficacy has been consistently demonstrated in treating conditions such as acute bronchitis, otitis media, pharyngolaryngitis, and skin and skin structure infections[1].

Extended-Release Formulations

Recent clinical trials have focused on extended-release formulations of cefaclor. These studies have shown that extended-release cefaclor in 375-mg and 500-mg doses, administered twice daily, demonstrates tolerability and efficacy comparable to immediate-release cefaclor 250 mg administered three times a day. This formulation enhances patient compliance due to the reduced dosing frequency[3].

Mechanism of Action

Cefaclor works by inhibiting the activity of penicillin-binding proteins (PBPs), which are crucial for the synthesis and maintenance of the bacterial cell wall. By disrupting the formation of the peptidoglycan layer, cefaclor leads to cell wall instability and ultimately bacterial cell death. This mechanism is specific to bacteria, minimizing potential side effects on human cells[1].

Market Analysis

Global Market Size and Growth

As of 2024, the global Cefaclor market size is estimated to be USD 162.5 million. This market is projected to grow at a compound annual growth rate (CAGR) of 4.50% from 2024 to 2031, reaching USD 221.1 million by 2031[2].

Regional Market Breakdown

• North America: Holds more than 40% of the global revenue, with a market size of USD 65 million in 2024 and a CAGR of 2.7% from 2024 to 2031.
• Europe: Accounts for more than 30% of the global revenue, with a market size of USD 48.75 million in 2024 and a CAGR of 3.0% from 2024 to 2031.
• Asia Pacific: Represents around 23% of the global revenue, with a market size of USD 37.38 million in 2024 and a CAGR of 6.5% from 2024 to 2031.
• Latin America: Holds more than 5% of the global revenue, with a market size of USD 8.13 million in 2024 and a CAGR of 3.9% from 2024 to 2031.
• Middle East and Africa: Accounts for around 2% of the global revenue, with a market size of USD 3.25 million in 2024 and a CAGR of 4.2% from 2024 to 2031[2].

Market Segmentation

The Cefaclor market is segmented based on type, application, and distribution channel. The USP-type segment, which adheres to the rigorous quality standards set by the United States Pharmacopeia, dominates the market. This segment ensures formulations of exceptional purity, potency, and safety, instilling confidence among healthcare professionals and consumers[2].

Key Factors Influencing Market Growth

Increasing Incidence of Bacterial Infections

The global rise in bacterial infections is a significant driver of the Cefaclor market. As the incidence of these infections increases, the demand for effective antibiotics like cefaclor also grows[2].

Awareness of Antibiotic Resistance

The growing awareness of antibiotic resistance has led to a greater emphasis on the development and use of antibiotics that are less likely to contribute to resistance. Cefaclor, with its established efficacy and safety profile, is well-positioned to meet this need[2].

Development of New Formulations

The introduction of new formulations, such as extended-release tablets, enhances patient compliance and improves the overall therapeutic outcome. These advancements are expected to boost sales and market growth[2][3].

Projections and Future Outlook

By 2030, the global Cefaclor market is forecasted to reach USD 282.9 million, growing at a CAGR of 4.2% from 2024 to 2030. This growth is driven by increasing demand, new formulations, and the need for effective antibiotics in the face of rising bacterial infections and antibiotic resistance[5].

Key Takeaways

• Clinical Trials: Cefaclor has completed the highest phase of clinical trials and is globally approved.
• Mechanism of Action: Targets PBPs to disrupt bacterial cell wall formation.
• Global Market Size: Estimated at USD 162.5 million in 2024, projected to grow to USD 221.1 million by 2031.
• Regional Growth: North America, Europe, and Asia Pacific are significant markets with varying growth rates.
• Market Drivers: Increasing bacterial infections, awareness of antibiotic resistance, and new formulations.
• Future Outlook: Projected to reach USD 282.9 million by 2030 with a CAGR of 4.2%.

FAQs

What is the primary mechanism of action of Cefaclor?

Cefaclor works by inhibiting the activity of penicillin-binding proteins (PBPs), disrupting the formation of the bacterial cell wall and leading to bacterial cell death[1].

What are the common indications for Cefaclor?

Cefaclor is commonly prescribed for treating bacterial infections such as acute bronchitis, otitis media, pharyngolaryngitis, skin and skin structure infections, and other bacterial infections[1].

What is the current global market size of Cefaclor?

As of 2024, the global Cefaclor market size is estimated to be USD 162.5 million[2].

What is the projected growth rate of the Cefaclor market from 2024 to 2031?

The Cefaclor market is projected to grow at a compound annual growth rate (CAGR) of 4.50% from 2024 to 2031[2].

Which regions are the major markets for Cefaclor?

North America, Europe, and Asia Pacific are the significant markets for Cefaclor, with North America holding more than 40% of the global revenue[2].

What are the key factors driving the growth of the Cefaclor market?

The key factors include the increasing incidence of bacterial infections, growing awareness of antibiotic resistance, and the development of new formulations[2].

Sources

1. Deep Scientific Insights on Cefaclor's R&D Progress, Mechanism of Action, and Drug Target. Synapse Patsnap.
2. Global Cefaclor Market Report 2024. Cognitive Market Research.
3. Cefaclor revisited. PubMed.
4. Determination That CECLOR CD (Cefaclor Extended-Release Tablets) 375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register.
5. Cefaclor - Market, Report Size, Worth, Revenue, Growth, Industry. Valuates Reports.