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ceftazidime/NXL104 + metronidazole

Phase 2

Complicated Intra-abdominal Infections | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 3, 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 Enrollment204
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00752219Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal InfectionsPHASE2 COMPLETED 204Mar 31, 2009Dec 31, 2009Jul 3, 201845 United States, Bulgaria +6
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Study Endpoints
Primary Endpoints
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Test of cure visit: 2 weeks post-therapy (Day 28)

Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.

Secondary Endpoints
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response at the Late Follow-up Visit
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Microbiological Response at the Test of Cure Visit
Test of cure visit: 2 weeks post-therapy (Day 28)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NXL104/CAZ/MTZEXPERIMENTALNXL104/ceftazidime + metronidazole
MeropenemACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ceftazidime/NXL104 + metronidazoleDRUGIV TID
meropenemDRUGIV TID
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: * complicated intra-abdominal infections Exclusion Criteria: * infections limited to hollow viscus * ischemic bowel disease without perforation * acute suppurative cholangitis * acute necrotizing pancreatitis * pts to undergo stated abdominal repair, open abdomen technique or ...

Countries:United StatesBulgariaFranceIndiaLebanonPolandRomaniaRussia
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