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Vancomycin or Semi-Synthetic Penicillins

Phase 3

Infections | Small molecule | Infectious Disease |Novartis AG|Last Updated: Jul 13, 2012

Target and mechanism

ModalitySmall molecule

Also known as Vancomycin or Semi-Synthetic Penicillins (SSPs)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Vancomycin or Semi-Synthetic Penicillins · 1 trial · 1 indication

Phase 3 1
NCT01184872Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue InfectionsInfections
COMPLETED120 Analytics
PHASE3COMPLETED
Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
Baseline and 7 to 14 days after end of therapy

Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.

Secondary Endpoints

Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Baseline and 7 to 14 days after end of therapy
Duration of Treatment (Intravenous)
Up to 28 days
Duration of Treatment (Intravenous and Oral)
Up to 28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DaptomycinEXPERIMENTALPatients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.
Vancomycin or Semi-Synthetic Penicillins (SSPs)ACTIVE_COMPARATORPatients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Interventions

NameTypeDescription
DaptomycinDRUGPatients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.
Vancomycin or Semi-Synthetic Penicillins (SSPs)DRUGPatients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion criteria: Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours. Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or witho...

Countries:AustriaGermanyItalyRussiaSpain
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