Drug Use Investigation of Linezolid (Regulatory Post Marketing Commitment Plan)

Condition(s) targeted: Staphylococcal Infections

Intervention: Linezolid (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Drug use investigation of Zyvox for patients with MRSA infection desease. The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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.

Official title: Drug Use Investigation of Zyvox (Regulatory Post Marketing Commitment Plan)

Study design: Case-Only, Prospective

Primary outcome:

Factors considered to affect the safety and/or efficacy of this drug.

The incidence of adverse drug reactions in this surveillance.

Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).

Secondary outcome: This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes.

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Linezolid.

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

Starting date: February 2007
Ending date: August 2009
Last updated: April 23, 2008