Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
- Registration Number
- NCT00666276
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1004
- Patients need to be administered Linezolid in order to be enrolled in the surveillance.
- Patients not administered Linezolid.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description linezolid (Zyvox) linezolid (Zyvox) Patients taking Linezolid.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. Baseline to 8 weeks The adverse drug reaction that have not been listed in Japanese package insert.
Number of Participants With Adverse Drug Reactions(ADRs). 8 weeks All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.
Factors Considered to Affect the Safety of Linezolid - Gender. 8 weeks Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Age 8 weeks Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. 8 weeks Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. 8 weeks Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. 8 weeks Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Route of Administration. 8 weeks Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Weight. 8 weeks Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. 8 weeks Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. 8 weeks Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.
- Secondary Outcome Measures
Name Time Method