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

• ClinicalTrials.gov Identifier: NCT00666276
• Recruitment Status: Completed
• First Posted: April 24, 2008
• Results First Posted: July 2, 2012
• Last Update Posted: July 2, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Staphylococcal Infections	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 Design

• Study Type: Observational
• Actual Enrollment: 1004 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
• Study Start Date: February 2007
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A5951142 prescribes the Linezolid.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not administered Linezolid.

Contacts and Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00666276
• Other Study ID Numbers: A5951142
• First Posted: April 24, 2008
• Results First Posted: July 2, 2012
• Last Update Posted: July 2, 2012
• Last Verified: May 2012

Additional relevant MeSH terms:

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Linezolid; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action