N/A Completed N=1,004

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

Staphylococcal Infections

Source: ClinicalTrials.gov NCT00666276 ↗

Enrolled (actual)

1,004

Serious AEs

5.1%

Results posted

Jul 2012

Primary outcomePrimary: Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. — 1; 1; 1; 1 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.	1; 1; 1; 1; 1; 1	—
PRIMARY Number of Participants With Adverse Drug Reactions(ADRs).	163	—
PRIMARY Factors Considered to Affect the Safety of Linezolid - Gender.	109; 54	=0.712
PRIMARY Factors Considered to Affect the Safety of Linezolid - Age	122; 41	=0.257
PRIMARY Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.	137; 26	=0.082
PRIMARY Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.	125; 38	=0.462
PRIMARY Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.	53; 110	<0.001 sig
PRIMARY Factors Considered to Affect the Safety of Linezolid - Route of Administration.	29; 116; 18	=0.018 sig
PRIMARY Factors Considered to Affect the Safety of Linezolid - Weight.	108; 20	=0.311
PRIMARY Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.	9; 154	=0.044 sig
PRIMARY Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.	87; 76	=0.008 sig

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Patients not administered Linezolid.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00666276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.