CLINICAL TRIALS PROFILE FOR TELITHROMYCIN

All Clinical Trials for Telithromycin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00132938 ↗	PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis	Completed	Sanofi	Phase 4	2004-01-01	Primary Objective: - The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1). Secondary Objectives: The secondary objectives of the study are: - To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1); - To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits; - To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1); - To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.
NCT00132951 ↗	KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections	Terminated	Sanofi	Phase 4	2004-10-01	The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.
NCT00164112 ↗	Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2004-11-01	Studies have previously shown that a broad drug interaction screening can be performed using enzyme specific probes such as oral caffeine for CYP1A2, N-acetyltrasferase-2 (NAT-2), and xanthine oxidase (XO), warfarin plus vitamin K for CYP2C9, omeprazole for CYP 2C19, dextromethorphan for CYP2D6, and midazolam for CYP3A4/5. This combination of probes has been validated in the Cooperstown 5+1 Cocktail (5+1).1 The use of the 5+1 cocktail provides information on the drug metabolizing enzymes that metabolize 90% of hepatically eliminated drugs for a fraction of the costs of the individual studies. Using a cocktail of biomarkers reduces the overall cost of drug interaction screening. The purpose of this study is to evaluate the effects of three Food and Drug Administration (FDA) approved oral antibiotics (azithromycin, telithromycin, and levofloxacin) on metabolism of other medications when taken together. This will be determined by the measuring the activity of drug metabolizing enzymes following administration of certain drug probes (caffeine, dextromethorphan, omeprazole, midazolam, and warfarin with vitamin K). A total of 16 subjects will complete four phases of the study: 1) Cooperstown 5+1 alone, 2) Azithromycin plus Cooperstown 5+1, 3) Telithromycin plus Cooperstown 5+1, and 4) Levofloxacin plus Cooperstown 5+1.

Clinical Trial Conditions for Telithromycin

Condition Name

Condition Name for Telithromycin
Intervention	Trials
Pneumonia	4
Bronchitis, Chronic	3
Otitis Media	2

Condition MeSH

Condition MeSH for Telithromycin
Intervention	Trials
Pneumonia	7
Bronchitis, Chronic	6
Bronchitis	6

Clinical Trial Locations for Telithromycin

Trials by Country

Trials by Country for Telithromycin
Location	Trials
United States	14
Japan	3
Chile	3
Argentina	3
Costa Rica	3

Trials by US State

Trials by US State for Telithromycin
Location	Trials
New Jersey	8
Delaware	1
Arizona	1
Massachusetts	1
Louisiana	1

Clinical Trial Progress for Telithromycin

Clinical Trial Phase

Clinical Trial Phase for Telithromycin
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Telithromycin
Clinical Trial Phase	Trials
Completed	16
Terminated	9
Unknown status	2

Clinical Trial Sponsors for Telithromycin

Sponsor Name

Sponsor Name for Telithromycin
Sponsor	Trials
Sanofi	21
CPL Associates	2
Enanta Pharmaceuticals	1

Sponsor Type

Sponsor Type for Telithromycin
Sponsor	Trials
Industry	25
Other	12

Telithromycin: Clinical Trials, Market Analysis, and Projections

Introduction to Telithromycin

Telithromycin, marketed under the brand name Ketek, is a ketolide antibiotic derived from the 14-membered macrolides. It is specifically designed to combat bacterial infections, particularly those caused by erythromycin-resistant pneumococci. Here, we will delve into the clinical trials, market analysis, and future projections for telithromycin.

Clinical Trials and Safety Profile

Initial Approval and Clinical Efficacy

Telithromycin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired pneumonia (CAP) in adults. Clinical trials demonstrated its efficacy, with a study presented at the American Thoracic Society showing that telithromycin had a higher clinical cure rate compared to other standard antibiotics for CAP. The study involved 505 patients and showed a significant difference in clinical cure rates, particularly in patients with documented pneumococcal CAP[3].

Safety Concerns and Updates

Despite its clinical efficacy, telithromycin has faced several safety concerns. The FDA and sanofi-aventis revised the prescribing information to include bolded warnings about hepatic events and its use in patients with myasthenia gravis. Reports of exacerbations of myasthenia gravis, including life-threatening acute respiratory failure, led to the recommendation that telithromycin should not be used in these patients unless no other therapeutic alternatives are available[1].

Pediatric Clinical Trials

Sanofi-aventis voluntarily paused enrollment in pediatric clinical trials for telithromycin to ensure the trial design aligns with the FDA's current guidelines. This pause was not due to any identified safety reasons but rather to confirm consistency with regulatory standards[1].

Market Analysis

Market Size and Growth

The macrolide antibiotics market, which includes telithromycin, has seen robust growth. In 2022, the market size was valued at USD 50.9 billion and is projected to grow to USD 154.13 billion by 2032, with a compound annual growth rate (CAGR) of 13.10% during the forecast period (2023-2032)[2].

Market Segmentation

The macrolide antibiotics market is segmented by drugs, with azithromycin dominating the market due to its broad-spectrum effectiveness. However, telithromycin remains a significant player, especially in treating respiratory infections such as CAP. The market is also segmented by route of administration, with oral formulations being the most prevalent due to their convenience, affordability, and high patient compliance[2].

Geographical Insights

North America is the largest region in the macrolide antibiotics market, followed by other regions such as Asia-Pacific, Western Europe, and Eastern Europe. The growth in these regions is driven by increasing antibiotic resistance, approvals for new formulations, and a rise in infectious diseases[5].

Market Drivers and Trends

Increasing Antibiotic Resistance

The rise in antibiotic-resistant bacteria is a significant driver for the macrolide antibiotics market, including telithromycin. As traditional antibiotics become less effective, newer antibiotics like telithromycin, which are active against erythromycin-resistant pneumococci, gain importance[5].

Rise in Respiratory Infections

Respiratory infections, such as CAP, are a major indication for telithromycin. The increasing incidence of these infections, particularly in the elderly population, contributes to the market growth[3].

Government and Healthcare Initiatives

Government initiatives and healthcare policies aimed at combating infectious diseases also drive the market. Increased awareness and diagnostics, along with the growth in telemedicine and online pharmacy services, further boost the demand for macrolide antibiotics[5].

Future Projections

Market Growth

The macrolide antibiotics market, including telithromycin, is expected to continue its strong growth. By 2028, the market is projected to reach USD 91.64 billion at a CAGR of 11.6%. This growth is attributed to factors such as the rise in respiratory infections, increased global geriatric population, and advancements in telemedicine and online pharmacy services[5].

Investment Opportunities

The growing demand for effective antibiotics presents significant investment opportunities. Companies can focus on developing new formulations, improving distribution channels, and enhancing patient compliance through innovative delivery systems.

Key Takeaways

• Clinical Efficacy: Telithromycin has demonstrated superior clinical cure rates in treating CAP compared to other standard antibiotics.
• Safety Concerns: Despite its efficacy, telithromycin has safety concerns, particularly in patients with myasthenia gravis and hepatic events.
• Market Growth: The macrolide antibiotics market, including telithromycin, is projected to grow significantly due to increasing antibiotic resistance and rising respiratory infections.
• Market Drivers: Key drivers include the rise in antibiotic-resistant bacteria, government and healthcare initiatives, and advancements in telemedicine and online pharmacy services.

FAQs

Q: What is telithromycin used for?

Telithromycin is used for the treatment of community-acquired pneumonia (CAP) in adults, particularly effective against erythromycin-resistant pneumococci.

Q: What are the safety concerns associated with telithromycin?

Telithromycin has been associated with exacerbations of myasthenia gravis, including life-threatening acute respiratory failure, and hepatic events. It is contraindicated with certain medications like cisapride and pimozide.

Q: Why was the enrollment in pediatric clinical trials for telithromycin paused?

The enrollment was paused to ensure the trial design aligns with the FDA's current guidelines, not due to any identified safety reasons.

Q: How is the macrolide antibiotics market segmented?

The market is segmented by drugs (e.g., azithromycin, telithromycin), route of administration (oral, parenteral), indication (respiratory tract infections, skin infections), and distribution channels (hospital pharmacies, drug stores).

Q: What are the key drivers of the macrolide antibiotics market growth?

Key drivers include increasing antibiotic resistance, approvals for new formulations, rise in infectious diseases, government and healthcare initiatives, and growth in telemedicine and online pharmacy services.

Sources

1. Sanofi-aventis announces update to KETEK® (telithromycin) U.S. prescribing information. Sanofi US.
2. Macrolide Antibiotics Market Analysis. Market Research Future.
3. New Study Demonstrates Clinical Efficacy of Telithromycin Superior to Comparator Antibiotics in Treating Community-Acquired Pneumonia. Sanofi US.
4. Telithromycin: A Ketolide Antibiotic for Treatment of Respiratory Tract Infections. Oxford Academic.
5. Macrolide Antibiotics Market Growth Analysis With Investment Opportunities For 2024-2033. EIN Presswire.