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pristinamycin

Phase 3

Tonsillitis | Small molecule | ENT |Sanofi|Last Updated: Mar 17, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment395

FDA Designations

No designations recorded

Clinical trial landscape

pristinamycin · 1 trial · 1 indication

Phase 3 1
NCT00393744Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in ChildrenTonsillitis
COMPLETED395 Analytics
PHASE3COMPLETED
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
TonsillitisUnlock trial analytics

Study Endpoints

Primary Endpoints

bacterial eradication
at V3

Secondary Endpoints

adverse events
during the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
pristinamycinDRUG50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
amoxicillinDRUG50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
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Eligibility Criteria

Age Range6 Years to 25 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * subjects of both sexes * aged between 6 and 25 years, * weight : ≥ 20kg * with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy) * confirmation by...

Countries:France
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Frequently asked questions about pristinamycin

What is pristinamycin used for?

Pristinamycin is an investigational small molecule being studied for the treatment of tonsillitis, specifically tonsillitis induced by Streptococcus in children. It is in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes pristinamycin?

Pristinamycin is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of tonsillitis.

What phase is pristinamycin in?

Pristinamycin is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and efficacy for the treatment of tonsillitis.

What clinical trials is pristinamycin in?

Pristinamycin has one completed Phase 3 clinical trial registered under NCT00393744. This trial, titled 'Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children,' enrolled 395 participants in France and included children aged 6 years and older.

Is pristinamycin the same as amoxicillin?

No, pristinamycin is not the same as amoxicillin. Pristinamycin is an investigational drug being studied as a potential treatment for tonsillitis, while amoxicillin is an established antibiotic used as an active comparator in clinical trials. The two drugs have different mechanisms of action and chemical structures.