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meropenem

Phase 4FDA approved

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

meropenem development status

FDA approval on record May 25, 2005 as Merrem Iv
Approval holderPfizer
ApplicationNDA050706
Highest phase Phase 4 (NCT00318552)
Phase scored for PFEPhase 3
Registered trials 26 across 14 sponsors since May 2003

meropenem target and mechanism

ModalitySmall molecule

Also known as meropenem (active comparator), Merrem

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

meropenem clinical trials

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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Frequently asked questions about meropenem

What is meropenem used for?

Meropenem is studied for the treatment of skin infections, including complicated skin and skin structure infections such as abscesses and cellulitis. It is an infectious disease therapy developed by Pfizer, Inc. (PFE) and has been evaluated in a Phase 3 trial in patients aged 13 years and older.

Who makes meropenem?

Meropenem is developed by Pfizer, Inc., which trades under the ticker PFE. The company sponsored the Phase 3 clinical program evaluating meropenem in complicated skin and skin structure infections.

What phase is meropenem in?

Meropenem is in Phase 3 development for skin infections. The Phase 3 trial has been completed, and no active trials are currently listed. Meropenem is an investigational therapy in this program and is not described as approved for this indication.

What clinical trials is meropenem in?

Meropenem has been evaluated in one completed Phase 3 trial, NCT00619710, titled Complicated Skin and Skin Structure Infections. The trial enrolled 1,000 participants aged 13 years and older, was randomized, double-blind, and used an active-controlled design.

Is meropenem the same as meropenem (active comparator)?

Yes. Meropenem is also referred to as meropenem (active comparator) in the context of the Phase 3 trial NCT00619710, where it was used as the active comparator arm. Both names refer to the same small molecule developed by Pfizer, Inc. (PFE).