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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00666276
First received: April 22, 2008
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention
Staphylococcal Infections
Drug: linezolid (Zyvox)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: Yes ]
    The adverse drug reaction that have not been listed in Japanese package insert.

  • Number of Participants With Adverse Drug Reactions(ADRs). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.


Enrollment: 1004
Study Start Date: February 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666276

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00666276     History of Changes
Other Study ID Numbers: A5951142
Study First Received: April 22, 2008
Results First Received: March 28, 2012
Last Updated: May 29, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014