Vancomycin Resistance Enterococcus Faecium
Conditions
Keywords
VRE, Japanese, Post Marketing Surveillance
Brief summary
To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.
Interventions
DRUGZyvox (linezolid)
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject to whom Zyvox (linezolid) was administered. * Infected subject with Vancomycin resistance Enterococcus faecium.
Exclusion criteria
* Infected subject with MRSA and other organism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions. | Baseline to 8 weeks | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product. |
| Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. | Baseline to 8 weeks | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reactions Unlisted in Japanese Package Insert. | Baseline to 8 weeks | The adverse drug reactions that have not been included in Japanese package insert. |
Participant flow
Recruitment details
This was a non-interventional retrospective study.
Participants by arm
| Arm | Count |
|---|---|
| Linezolid Participants who have been treated with Zyvox (linezolid). | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Linezolid |
|---|---|
| Age, Customized <65 years | 12 participants |
| Age, Customized >=65 years | 29 participants |
| Complications Absent | 0 participants |
| Complications Present | 41 participants |
| Past medical history Absent | 18 participants |
| Past medical history Present | 22 participants |
| Past medical history Unknown | 1 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 41 |
| serious Total, serious adverse events | 9 / 41 |
Outcome results
Primary
Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.
Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.
Time frame: Baseline to 8 weeks
Population: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. | 16 participants |
Primary
Number of Participants With Adverse Drug Reactions.
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.
Time frame: Baseline to 8 weeks
Population: Safety analysis population consisted of the participants that satisfied 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 Reactions. | Aspartate aminotransferase increased | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Platelet count decreased | 10 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Anaemia | 3 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | White blood cell count decreased | 3 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Superinfection | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Sepsis | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Histiocytosis haematophagic | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Pancytopenia | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Dizziness postural | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Neuropathy peripheral | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Diarrhoea | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Liver disorder | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Renal disorder | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Multi-organ failure | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Haemoglobin decreased | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Liver function test abnormal | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Blood alkaline phosphatase increased | 1 participants |
| Linezolid | Number of Participants With Adverse Drug Reactions. | Red blood cell count decreased | 1 participants |
Secondary
Adverse Drug Reactions Unlisted in Japanese Package Insert.
The adverse drug reactions that have not been included in Japanese package insert.
Time frame: Baseline to 8 weeks
Population: Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Linezolid | Adverse Drug Reactions Unlisted in Japanese Package Insert. | Sepsis | 1 participants |
| Linezolid | Adverse Drug Reactions Unlisted in Japanese Package Insert. | Multi-organ failure | 1 participants |
| Linezolid | Adverse Drug Reactions Unlisted in Japanese Package Insert. | Histiocytosis haematophagic | 1 participants |
| Linezolid | Adverse Drug Reactions Unlisted in Japanese Package Insert. | Neuropathy peripheral | 1 participants |
| Linezolid | Adverse Drug Reactions Unlisted in Japanese Package Insert. | Liver disorder | 1 participants |
| Linezolid | Adverse Drug Reactions Unlisted in Japanese Package Insert. | Renal disorder | 1 participants |