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Telithromycin

Phase 3

Asthma | Small molecule | Respiratory |Sanofi|Last Updated: Feb 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

Telithromycin · 5 trials · 6 indications

Phase 3 5
NCT00408135Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With InfectionsInfections
COMPLETED111 Analytics
NCT00638859Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired PneumoniaPneumonia
COMPLETED56 Analytics
NCT00638534Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis MediaOtitis Media
COMPLETED56 Analytics
NCT00273520TELICAST : Telithromycin in Acute Exacerbations of AsthmaAsthma
COMPLETED- Analytics
NCT00537563AMS VS MOXI Ketek vs Avelox in AMSMaxillary Sinusitis
COMPLETED351 Analytics
PHASE3COMPLETED
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
InfectionsUnlock trial analytics
PHASE3COMPLETED
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
PneumoniaUnlock trial analytics
PHASE3COMPLETED
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Otitis MediaUnlock trial analytics
PHASE3COMPLETED
TELICAST : Telithromycin in Acute Exacerbations of Asthma
AsthmaUnlock trial analytics
PHASE3COMPLETED
AMS VS MOXI Ketek vs Avelox in AMS
Maxillary SinusitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Patient's daily diary summary symptom scores/Morning diary PEFR
During the Study Conduct
To demonstrate equivalence in clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure (TOC) visit.
Days 17 to 24

Secondary Endpoints

Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit
Clinical efficacy: change in the symptoms and signs
Acceptability: compliance and willingness to take medication
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
telithromycin (HMR3647)DRUG -
TelithromycinDRUG -
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Eligibility Criteria

Age Range6 Months to 16 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Outpatients of weight from 7.0 kg. * For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings. * For de...

Countries:JapanUnited States
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Frequently asked questions about Telithromycin

What is Telithromycin used for?

Telithromycin is an investigational small molecule antibiotic being studied for respiratory and related infections, including acute exacerbations of asthma, maxillary sinusitis, acute otitis media, and community-acquired pneumonia. It is developed by Sanofi and has completed Phase 3 clinical trials for these indications.

What does Telithromycin target?

Telithromycin is a ketolide antibiotic that works by binding to the bacterial ribosome, inhibiting protein synthesis. It is designed to treat respiratory tract infections caused by susceptible bacteria, including those resistant to macrolides. The drug is being studied for its efficacy in conditions like sinusitis and pneumonia.

Who makes Telithromycin?

Telithromycin is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has conducted Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating respiratory infections.

What phase is Telithromycin in?

Telithromycin is in Phase 3 clinical development, with all four completed trials having reached this stage. It is not yet approved by regulatory authorities and remains investigational. The completed trials include studies in asthma, maxillary sinusitis, otitis media, and pneumonia.

What clinical trials is Telithromycin in?

Telithromycin has completed four Phase 3 trials: NCT00273520 (TELICAST) for acute asthma exacerbations, NCT00537563 comparing telithromycin to moxifloxacin in maxillary sinusitis, NCT00638534 for acute otitis media in children, and NCT00638859 for community-acquired pneumonia in children. All trials are completed.

Is Telithromycin the same as Ketek?

Telithromycin is the generic name for the drug marketed under the brand name Ketek. It is developed by Sanofi and has been studied in Phase 3 trials for respiratory infections. The drug is not yet approved and remains in clinical development.