Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00666276

Purpose

Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection disease.

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition	Intervention	Phase
Staphylococcal Infections	Drug: Linezolid	Phase IV

MedlinePlus related topics: Staphylococcal Infections

Drug Information available for: Linezolid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

Further study details as provided by Pfizer:

Primary Outcome Measures:

The incidence of adverse drug reactions in this surveillance. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

This surveillance is a non-interventional/observational surveillance and does not have any secondary outcomes. [ Time Frame: There is no secondary outcomes for this surveillance. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Linezolid Patients taking Linezolid.	Drug: Linezolid Zyvox Tablets 600mg, Zyvox Injection 600mg Dosage, Frequency: According to Japanese LPD, In adults, administer usually 600mg of linezolid twice daily (q 12 hours) for a total daily dose of 1200 mg. Duration: According to the protocol of A5951142, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 8 weeks after the first administration.

Groups/Cohorts

Assigned Interventions

Linezolid

Patients taking Linezolid.

Drug: Linezolid

Zyvox Tablets 600mg, Zyvox Injection 600mg

Dosage, Frequency: According to Japanese LPD, In adults, administer usually 600mg of linezolid twice daily (q 12 hours) for a total daily dose of 1200 mg.

Duration: According to the protocol of A5951142, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 8 weeks after the first administration.

Detailed Description:

All the patients whom an investigator prescribes the first Linezolid should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The patients whom an investigator involving A5951142 prescribes the Linezolid.

Criteria

Inclusion Criteria:

Patients need to be administered Linezolid in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Linezolid.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666276

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5951142
Study First Received:	April 22, 2008
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00666276 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Linezolid

Additional relevant MeSH terms:

Bacterial Infections
Protein Synthesis Inhibitors
Anti-Infective Agents
Staphylococcal Infections
Gram-Positive Bacterial Infections
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009