Staphylococcal Infections
Conditions
Brief 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.
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.
Interventions
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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients need to be administered Linezolid in order to be enrolled in the surveillance.
Exclusion criteria
* Patients not administered Linezolid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Baseline to 8 weeks | The adverse drug reaction that have not been listed in Japanese package insert. |
| Number of Participants With Adverse Drug Reactions(ADRs). | 8 weeks | 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. |
| Factors Considered to Affect the Safety of Linezolid - Gender. | 8 weeks | Number of participants with adverse drug reaction to determine whether male or female is significant risk factor. |
| Factors Considered to Affect the Safety of Linezolid - Age | 8 weeks | Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor. |
| Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. | 8 weeks | Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor. |
| Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. | 8 weeks | Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor. |
| Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. | 8 weeks | 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. |
| Factors Considered to Affect the Safety of Linezolid - Route of Administration. | 8 weeks | 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. |
| Factors Considered to Affect the Safety of Linezolid - Weight. | 8 weeks | 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. |
| Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. | 8 weeks | Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor. |
| Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. | 8 weeks | Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor. |
Participant flow
Recruitment details
This was an open label, prospective, multi-center non-interventional cohort study.
Participants by arm
| Arm | Count |
|---|---|
| Linezolid Participants who have been treated with Linezolid. | 970 |
| Total | 970 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 34 |
Baseline characteristics
| Characteristic | Linezolid |
|---|---|
| Age, Customized <65 years | 282 participants |
| Age, Customized >=65 years | 688 participants |
| Complications Absent | 73 participants |
| Complications Present | 897 participants |
| Sex: Female, Male Female | 308 Participants |
| Sex: Female, Male Male | 662 Participants |
| Target disease Deep-seated skin infection | 33 participants |
| Target disease Multiple infection | 141 participants |
| Target disease Other | 91 participants |
| Target disease Pneumonia | 377 participants |
| Target disease Secondary infection in injury, Burn and operative | 136 participants |
| Target disease Sepsis | 192 participants |
| Target disease Severity Mild | 68 participants |
| Target disease Severity Moderate | 455 participants |
| Target disease Severity Severe | 447 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 163 / 970 |
| serious Total, serious adverse events | 50 / 970 |
Outcome results
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Age | 122 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Age | 41 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs.p-value: =0.257Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. | 9 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs. | 154 participants |
Comparison: The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs.p-value: =0.044Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. | 53 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration. | 110 participants |
Comparison: The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs.p-value: <0.001Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Gender. | 109 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Gender. | 54 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs.p-value: =0.712Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. | 137 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions. | 26 participants |
Comparison: The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs.p-value: =0.082Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. | 87 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies. | 76 participants |
Comparison: The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs.p-value: =0.008Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. | 125 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions. | 38 participants |
Comparison: The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs.p-value: =0.462Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Route of Administration. | 29 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Route of Administration. | 116 participants |
| Linezolid-oral From Injection | Factors Considered to Affect the Safety of Linezolid - Route of Administration. | 18 participants |
Comparison: The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs.p-value: =0.018Fisher Exact
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Factors Considered to Affect the Safety of Linezolid - Weight. | 108 participants |
| Linezolid-female | Factors Considered to Affect the Safety of Linezolid - Weight. | 20 participants |
Comparison: The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs.p-value: =0.311Fisher Exact
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.
Time frame: Baseline to 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Hyperbilirubinaemia | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Superinfection | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Sepsis | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Thrombocytopenia | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Lactic acidosis | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Agitation | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Deep vein thrombosis | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Antithrombin III decreased | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Blood chloride increased | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert. | Blood sodium increased | 1 participants |
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.
Time frame: 8 weeks
Population: Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Number of Participants With Adverse Drug Reactions(ADRs). | 163 participants |