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

NCT00666276 | Completed Results

• 1 other identifier: A5951142
• Study Type: observational
• Target: 1,004
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Staphylococcal Infections

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

linezolid (Zyvox)

Patients taking Linezolid.

Drug: linezolid (Zyvox)

Interventions

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.

linezolid (Zyvox)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A5951142 prescribes the Linezolid.

You may qualify if:

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

You may not qualify if:

• Patients not administered Linezolid.

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: February 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 2, 2012
• Results First Posted: July 2, 2012

Record last verified: 2012-05