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Last Updated: November 14, 2019

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CLINICAL TRIALS PROFILE FOR TELITHROMYCIN

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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.
NCT00164112 Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes Completed Bassett Healthcare 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Telithromycin

Condition Name

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

Condition MeSH for Telithromycin
Intervention Trials
Pneumonia 7
Bronchitis, Chronic 6
Bronchitis 6
Otitis 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
Delaware 1
Arizona 1
Massachusetts 1
Louisiana 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 11
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
Bassett Healthcare 1
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Sponsor Type

Sponsor Type for Telithromycin
Sponsor Trials
Industry 25
Other 11
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