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OpenTrials
Completed

NCT Number: NCT00666276

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.

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Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients not administered Linezolid.

Treatment and study plan

linezolid (Zyvox)

Drug

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 24, 2008
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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