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Ceftazidime-avibactam

Phase 3

Complicated Intra-abdominal Infection | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 6, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment486
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01726023Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd InfectionsPHASE3 COMPLETED 486 — — Jan 1, 2013Mar 1, 2015Sep 6, 201730 China, South Korea +1
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Study Endpoints
Primary Endpoints
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
At the test of cure visit (Day 28 to35)

The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

Secondary Endpoints
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
At the end of treatment (EOT) (within 24 hours after last IV dose)
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
At the test of cure (TOC) (Day 28 to 35)
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
At the late follow up (LFU) (Day 42 to 49)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ceftazidime-Avibactam plus metronidazoleEXPERIMENTAL -
MeropenemACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Ceftazidime-avibactamDRUGCeftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
metronidazoleDRUGMetronidazole 500mg/100ml solution for infusion
MeropenemDRUGMeropenem powder for solution for infusion 1000mg
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Patient must be 18 to 90 years of age, inclusive, * Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy * Female of childbearing potential has had normal menstrual periods for 3 month...

Countries:ChinaSouth KoreaVietnam
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