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meropenem

Phase 3

Skin Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 1, 2017

Target and mechanism

ModalitySmall molecule

Also known as meropenem (active comparator)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,000

FDA Designations

No designations recorded

Clinical trial landscape

meropenem · 1 trial · 3 indications

Phase 3 1
NCT00619710Complicated Skin and Skin Structure InfectionsSkin Infection
COMPLETED1,000 Analytics
PHASE3COMPLETED
Complicated Skin and Skin Structure Infections
Skin InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary measure is clinical response after all antibacterial treatment is stopped).
7-28 days

Secondary Endpoints

clinical and microbiological response
Twice 3-28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMeropenem
2ACTIVE_COMPARATORImipenem-cilastatin

Interventions

NameTypeDescription
MeropenemDRUGIntravenous
Imipenem-cilastatinDRUGIntravenous
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections * Within 72 hours before enrollment or at the time of enr...

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