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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Staphylococcal Infections

Intervention: linezolid (Zyvox) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

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

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.

Number of Participants With Adverse Drug Reactions(ADRs).

Factors Considered to Affect the Safety of Linezolid - Gender.

Factors Considered to Affect the Safety of Linezolid - Age

Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.

Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.

Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.

Factors Considered to Affect the Safety of Linezolid - Route of Administration.

Factors Considered to Affect the Safety of Linezolid - Weight.

Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.

Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.

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.

Eligibility

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.

Locations and Contacts

Additional Information

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

Starting date: February 2007
Last updated: May 29, 2012

Page last updated: August 23, 2015

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