NCT00666276

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,004 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-04-24
• Last updated: 2012-07-02
• Results posted: 2012-07-02