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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR TELITHROMYCIN

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Clinical Trials for Telithromycin

Trial ID Title Status Sponsor Phase Summary
NCT00132938 PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis Completed Sanofi Phase 4 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 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 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.
NCT00164112 Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes Completed Bassett Healthcare Phase 4 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.
NCT00174694 CHOOSE : Telithromycin, Acute Bacterial Sinusitis Completed Sanofi Phase 4 Primary objective: - To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS). Secondary objective(s): - To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits, - To assess the rate of clinical relapse at the follow-up visit (Day 41-49), - To assess health economic outcome until follow-up visit (Day 41-49), - To assess quality of life up to the follow-up visit (Day 41-49), - To compare the safety of telithromycin and amoxicillin-clavulanic acid, - To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.
NCT00174811 Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections Terminated Sanofi Phase 3 The clinical activity of telithromycin vs. cefuroxime in children with acute infections of the middle ear, ages 6 months to 59 months old will be studied.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Telithromycin

Condition Name

Condition Name for Telithromycin
Intervention Trials
Pneumonia 4
Bronchitis, Chronic 3
Respiratory Tract Infections 2
Maxillary Sinusitis 2
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Condition MeSH

Condition MeSH for Telithromycin
Intervention Trials
Pneumonia 7
Bronchitis, Chronic 6
Bronchitis 6
Acute Disease 3
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Clinical Trial Locations for Telithromycin

Trials by Country

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

Trials by US State for Telithromycin
Location Trials
New Jersey 8
South Carolina 1
Delaware 1
Arizona 1
Massachusetts 1
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Clinical Trial Progress for Telithromycin

Clinical Trial Phase

Clinical Trial Phase for Telithromycin
Clinical Trial Phase Trials
Phase 4 14
Phase 3 10
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Telithromycin
Clinical Trial Phase Trials
Completed 15
Terminated 9
Unknown status 2
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Clinical Trial Sponsors for Telithromycin

Sponsor Name

Sponsor Name for Telithromycin
Sponsor Trials
Sanofi 21
CPL Associates 2
Chosun University Hospital 1
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Sponsor Type

Sponsor Type for Telithromycin
Sponsor Trials
Industry 24
Other 10
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Serving hundreds of leading biopharmaceutical companies globally:

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