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Antibiotic

Phase 3

Pneumonia, Pneumococcal | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 26, 2011

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
UNCONTROLLED
Total Trials1
Total Enrollment230
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00035269New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)PHASE3 COMPLETED 230 — — Dec 1, 2001May 1, 2003Apr 26, 201146 United States, Slovakia +2
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Study Endpoints
Primary Endpoints
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
Secondary Endpoints
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AntibioticDRUG -
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Eligibility Criteria
Age Range13 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites46

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: * Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia. * The patient must have S. pneumoniae...

Countries:United StatesSlovakiaSpainTaiwan
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