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MERREM I.V. as a 3 hour infusion every 8 hours

Phase 3

Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 1, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00050401Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory SupportPHASE3 COMPLETED 500Jul 1, 2002Sep 1, 2004Sep 1, 201710 United States
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MERREM I.V. 2g as a 3 hour infusion every 8 hoursDRUG -
vancomycin I.V. 1 g every 12 hoursDRUG -
tobramycin I.V. 5 mg/kg every 24 hoursDRUG -
MERREM I.V. 1g as a 30 minute infusion every 8 hoursDRUG -
MERREM I.V. 500 mg as a 3 hour infusion every 8 hoursDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility * Diagnosis of hospital-acquired pneumonia requiring mechanical ...

Countries:United States
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