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

Staphylococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666276
• Other study ID #: A5951142
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: May 29, 2012
• Start date: February 2007
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not administered Linezolid.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Staphylococcal Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes

External Links

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