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Standard care

Phase 2

Soft Tissue Infections | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment313

FDA Designations

No designations recorded

Clinical trial landscape

Standard care · 1 trial · 1 indication

Phase 2 1
NCT00303589A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure InfectionsSoft Tissue Infections
COMPLETED313 Analytics
PHASE2COMPLETED
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
Soft Tissue InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical cure rate.
Event driven

Secondary Endpoints

Time to clinical cure
Event driven
Time to resolution of signs and symptoms of skin or soft tissue infection
Event driven
Bacteriological outcome
Event driven
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Standard careDRUGAs prescribed
beta-lactamDRUG750mg iv q8h
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites62

Inclusion Criteria: * adult patients, \>=18 years of age; * skin or skin structure infection requiring hospitalization; * clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment; * material from site of infec...

Countries:United StatesArgentinaBulgariaEstoniaGermanyHungaryLatviaLithuaniaPeruRomaniaSouth Africa
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Frequently asked questions about Standard care

What is Standard care used for in Soft Tissue Infections?

Standard care is a small molecule being studied for the treatment of soft tissue infections. It is currently in Phase 2 clinical development, with one completed trial involving 313 hospitalized patients with skin and skin structure infections. The drug is being developed by Roche Holding AG.

Who makes Standard care?

Standard care is being developed by Roche Holding AG, a pharmaceutical company traded under the ticker RHHBY. The drug is in Phase 2 clinical development for soft tissue infections, an infectious disease indication. One clinical trial has been completed to evaluate its use in this setting.

What phase is Standard care in?

Standard care is in Phase 2 clinical development. It is an investigational small molecule being studied for soft tissue infections. One Phase 2 trial has been completed, and the drug has not yet been approved for any use. It remains under clinical investigation.

What clinical trials is Standard care in?

Standard care has been studied in one clinical trial, NCT00303589, titled "A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections." This Phase 2 trial was completed and enrolled 313 participants with soft tissue infections across multiple countries, including the United States, Argentina, and Germany.

Is Standard care the same as Beta-Lactam?

Standard care is the drug name used in the context of a clinical trial that evaluated a beta-lactam antibiotic. The trial NCT00303589 studied a beta-lactam in hospitalized patients with skin and skin structure infections. Standard care refers to the treatment being investigated in this Phase 2 study.