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

Pfizer

Status: Completed

Conditions: Staphylococcal Infections

Treatments: Drug: linezolid (Zyvox)

Study type: Observational

Funder types: Industry

Identifiers

NCT00666276

A5951142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,004 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not administered Linezolid.

Trial design

1,004 participants in 1 patient group

linezolid (Zyvox)

Description:

Patients taking Linezolid.

Treatment:

Drug: linezolid (Zyvox)