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Oxacillin

Phase 3

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 14, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment739
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00037050Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive BacteriaPHASE3 COMPLETED 739Apr 1, 2002Jul 1, 2005Sep 14, 2009 -
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Study Endpoints
Primary Endpoints
The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
The empiric treatment of patients with gram-positive catheter-related bloodstream infections.
Secondary Endpoints
Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LinezolidDRUG -
VancomycinDRUG -
OxacillinDRUG -
DicloxacillinDRUG -
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Eligibility Criteria
Age Range13 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with a central indwelling catheter with signs and symptoms of infection Exclusion Criteria: * Patients with tunneled catheter which cannot be removed. * Patients with evidence of endovascular infection including endocarditis. * Patients with infection of permanent i...

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