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CXA-201

Phase 3

Complicated Urinary Tract Infection | Small molecule | Nephrology |Merck & Company, Inc.|Last Updated: Oct 25, 2018

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment558
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01345929Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including PyelonephritisPHASE3 COMPLETED 558 — — Jun 20, 2011Sep 4, 2013Oct 25, 201876 United States, Brazil +15
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Study Endpoints
Primary Endpoints
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population
Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
Secondary Endpoints
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CXA-201 as treatment for cUTIEXPERIMENTALCXA-201 IV infusion (1500mg q8) for 7 days
Levofloxacin as treatment for cUTIACTIVE_COMPARATORLevofloxacin IV infusion (750mg qd) for 7 days
Interventions
NameTypeDescription
CXA-201DRUGCXA-201 IV infusion (1500mg q8) for 7 days
LevofloxacinDRUGLevofloxacin IV infusion (750mg qd) for 7 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites76

Inclusion Criteria: 1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines). 2...

Countries:United StatesBrazilColombiaEstoniaGeorgiaGermanyHungaryIsraelLatviaMexicoMoldovaRomaniaRussiaSerbiaSlovakiaSouth AfricaThailand
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