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NXL104/ceftazidime

Phase 2

Complicated Urinary Tract Infection | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: May 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment137
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00690378Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract InfectionsPHASE2 COMPLETED 137 — — Nov 1, 2008Jul 1, 2010May 25, 201859 United States, Jordan +1
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Study Endpoints
Primary Endpoints
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
5 to 9 days post-therapy

Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL

Secondary Endpoints
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
4 to 6 weeks post-therapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALNXL/104 ceftazidime
2ACTIVE_COMPARATORcomparator 4 x daily
Interventions
NameTypeDescription
NXL104/ceftazidimeDRUG125mg/500mg TID
Imipenem/CilastatinDRUG4 x daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: * Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens Exclusion Criteria: * ileal loops or vesicoureteral reflux * complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess. * fungal urinary tract infec...

Countries:United StatesJordanLebanon
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