Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

NCT ID: NCT00666276

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1004 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2011-04-30

Brief Summary

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 Package Insert (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.

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.

Conditions

Staphylococcal Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

linezolid (Zyvox)

Patients taking Linezolid.

linezolid (Zyvox)

Intervention Type: DRUG

Zyvox Tablets 600mg, Zyvox Injection 600mg Dosage, Frequency: According to Japanese Package Insert, 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.

Interventions

linezolid (Zyvox)

Zyvox Tablets 600mg, Zyvox Injection 600mg Dosage, Frequency: According to Japanese Package Insert, 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients not administered Linezolid.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

A5951142

Identifier Type: -

Identifier Source: org_study_id