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CXA-201 and metronidazole

Phase 3

Complicated Intra-abdominal Infection | Small molecule | Other |Merck & Company, Inc.|Last Updated: Nov 16, 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 Enrollment494
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01445678Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal InfectionsPHASE3 COMPLETED 494 — — Dec 23, 2011Oct 15, 2013Nov 16, 201861 United States, Argentina +13
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Study Endpoints
Primary Endpoints
The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
TOC; 26-30 days after start of study drug administration

Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.

Secondary Endpoints
The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population
TOC; 26-30 days after start of study drug administration
The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population
EOT; Within 24 hours of last study drug administration
The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population
EOT; Within 24 hours of last study drug administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CXA-201 and Metronidazole as treatment for cIAIEXPERIMENTAL -
Meropenem as treatment for cIAIACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CXA-201 and metronidazoleDRUGCXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
MeropenemDRUGMeropenem IV infusion (1000mg q8h) for 4-14 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites61

Inclusion Criteria: * Diagnoses of cIAI. * Subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug. Exclusion Criteria: * Simple appendicitis; acute suppurative cholan...

Countries:United StatesArgentinaBulgariaChileCroatiaEstoniaGermanyHungaryIsraelLatviaLithuaniaMoldovaPolandSerbiaSouth Korea
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