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

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 Overview

• Status: Completed
• Conditions: Staphylococcal Infections
• Intervention / Treatment: Drug: linezolid (Zyvox)

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.

• Study Type: Observational
• Enrollment (Actual): 1004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A5951142 prescribes the Linezolid.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not administered Linezolid.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

linezolid (Zyvox); Patients taking Linezolid.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	The adverse drug reaction that have not been listed in Japanese package insert.	Baseline to 8 weeks
Number of Participants With Adverse Drug Reactions(ADRs).	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.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Gender.	Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Age	Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.	Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.	Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.	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.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Route of Administration.	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.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Weight.	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.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.	Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.	8 weeks
Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.	Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.	8 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: April 22, 2008
• First Submitted That Met QC Criteria: April 23, 2008
• First Posted (Estimate): April 24, 2008

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: May 29, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: A5951142