At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
In Brief
An observational study evaluating linezolid (Zyvox) for Staphylococcal Infections. Completed, enrolled 1,004 participants.
Detailed 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.
Study Details
Timeline
Interventions
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.