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Vancomycin or Semi-Synthetic Penicillins

Phase 3

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

Vancomycin or Semi-Synthetic Penicillins 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

Vancomycin or Semi-Synthetic Penicillins clinical trials

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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Frequently asked questions about Vancomycin or Semi-Synthetic Penicillins

What is vancomycin or semi-synthetic penicillins used for?

Vancomycin or semi-synthetic penicillins are antibiotic treatments used for infections. They are studied in infectious disease, including complicated skin and soft tissue infections. In the Phase 3 trial NCT01184872, they served as the active comparator against which daptomycin was evaluated in elderly patients aged 65 years and older.

Who is developing vancomycin or semi-synthetic penicillins?

Novartis AG, which trades under the ticker NVS, is the developer associated with vancomycin or semi-synthetic penicillins. The company sponsored the Phase 3 study NCT01184872, which compared daptomycin with these antibiotics in elderly patients with complicated skin and soft tissue infections.

What phase is vancomycin or semi-synthetic penicillins in?

Vancomycin or semi-synthetic penicillins have been studied in a Phase 3 clinical trial. That study, NCT01184872, is completed and enrolled 120 participants. The trial was randomized and active controlled, meaning patients received either the study drug or vancomycin or semi-synthetic penicillins as the comparator.

What clinical trials are vancomycin or semi-synthetic penicillins in?

Vancomycin or semi-synthetic penicillins were evaluated in the Phase 3 trial NCT01184872, titled Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections. The trial enrolled 120 patients aged 65 years and older across Austria, Germany, Italy, Russia, and Spain, and it is now completed.

Is vancomycin or semi-synthetic penicillins the same as SSPs?

Yes, semi-synthetic penicillins are commonly abbreviated as SSPs, so vancomycin or semi-synthetic penicillins (SSPs) refers to the same antibiotic comparators. The abbreviation appears alongside the full name in reference to the active control arm used in the Phase 3 trial NCT01184872.

What infections were studied with vancomycin or semi-synthetic penicillins?

Vancomycin or semi-synthetic penicillins were studied in infections, specifically complicated skin and soft tissue infections. In the completed Phase 3 trial NCT01184872, they were the active control compared with daptomycin in patients aged 65 years and older, with enrollment of 120 participants across five European countries.