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Zyvox/ Linezolid

Phase 3

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 14, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

Zyvox/ Linezolid · 1 trial · 1 indication

Phase 3 1
NCT00035854New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)Bacterial Infections
COMPLETED13 Analytics
PHASE3COMPLETED
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
Bacterial InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigator's and sponsor's evaluation of patient clinical outcome.

Secondary Endpoints

Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Zyvox® / LinezolidDRUG -
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Eligibility Criteria

Age RangeN/A to 17 Years
SexALL
Healthy VolunteersNo
Study Sites21

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: * Hospitalized/chronic care pediatric patients (birth through 17 years) * Known infections due to vancomycin-resistant enterococcus sp...

Countries:United States
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Frequently asked questions about Zyvox/ Linezolid

What is Zyvox (linezolid) used for?

Zyvox, also known as linezolid, is an antibiotic used to treat bacterial infections. It is being studied for use in pediatric patients with infections caused by vancomycin-resistant Enterococcus, a specific type of bacteria. The drug is in Phase 3 clinical development for this indication.

What does Zyvox (linezolid) target?

Zyvox (linezolid) is a small molecule antibiotic that targets bacterial infections. It works by inhibiting bacterial protein synthesis, which stops the growth and spread of bacteria. This mechanism makes it effective against certain resistant bacteria, such as vancomycin-resistant Enterococcus.

Who makes Zyvox (linezolid)?

Zyvox (linezolid) is developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in treating bacterial infections.

What phase is Zyvox (linezolid) in?

Zyvox (linezolid) is in Phase 3 clinical development for the treatment of bacterial infections. It is an investigational drug and has not been approved by regulatory authorities for this specific use. The Phase 3 trial has been completed.

What clinical trials is Zyvox (linezolid) in?

Zyvox (linezolid) has one completed Phase 3 clinical trial, identified as NCT00035854. This trial studied the drug in pediatric patients with infections due to vancomycin-resistant Enterococcus. The trial enrolled 13 participants in the United States and was not blinded or controlled.

Is Zyvox the same as linezolid?

Yes, Zyvox is the brand name for linezolid. The drug is referred to by both names in clinical and medical contexts. Pfizer, Inc. develops Zyvox (linezolid) as a small molecule antibiotic for treating bacterial infections.