Trial Outcomes & Findings for Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE) (NCT NCT01224626)
NCT ID: NCT01224626
Last Updated: 2012-07-02
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
41 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2012-07-02
Participant Flow
This was a non-interventional retrospective study.
Participant milestones
| Measure |
Linezolid
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
Baseline characteristics by cohort
| Measure |
Linezolid
n=41 Participants
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Age, Customized
<65 years
|
12 participants
n=93 Participants
|
|
Age, Customized
>=65 years
|
29 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
|
Past medical history
Present
|
22 participants
n=93 Participants
|
|
Past medical history
Absent
|
18 participants
n=93 Participants
|
|
Past medical history
Unknown
|
1 participants
n=93 Participants
|
|
Complications
Present
|
41 participants
n=93 Participants
|
|
Complications
Absent
|
0 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
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.
Outcome measures
| Measure |
Linezolid
n=41 Participants
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Number of Participants With Adverse Drug Reactions.
Platelet count decreased
|
10 participants
|
|
Number of Participants With Adverse Drug Reactions.
Anaemia
|
3 participants
|
|
Number of Participants With Adverse Drug Reactions.
White blood cell count decreased
|
3 participants
|
|
Number of Participants With Adverse Drug Reactions.
Superinfection
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Sepsis
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Histiocytosis haematophagic
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Pancytopenia
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Dizziness postural
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Neuropathy peripheral
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Diarrhoea
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Liver disorder
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Renal disorder
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Multi-organ failure
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Aspartate aminotransferase increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Haemoglobin decreased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Liver function test abnormal
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Blood alkaline phosphatase increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions.
Red blood cell count decreased
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.
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.
Outcome measures
| Measure |
Linezolid
n=17 Participants
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.
The adverse drug reactions that have not been included in Japanese package insert.
Outcome measures
| Measure |
Linezolid
n=41 Participants
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Adverse Drug Reactions Unlisted in Japanese Package Insert.
Renal disorder
|
1 participants
|
|
Adverse Drug Reactions Unlisted in Japanese Package Insert.
Sepsis
|
1 participants
|
|
Adverse Drug Reactions Unlisted in Japanese Package Insert.
Histiocytosis haematophagic
|
1 participants
|
|
Adverse Drug Reactions Unlisted in Japanese Package Insert.
Neuropathy peripheral
|
1 participants
|
|
Adverse Drug Reactions Unlisted in Japanese Package Insert.
Liver disorder
|
1 participants
|
|
Adverse Drug Reactions Unlisted in Japanese Package Insert.
Multi-organ failure
|
1 participants
|
Adverse Events
Linezolid
Serious events: 9 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Linezolid
n=41 participants at risk
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Investigations
Platelet count decreased
|
12.2%
5/41 • Number of events 5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
4.9%
2/41 • Number of events 2
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal disorder
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Multi-organ failure
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Linezolid
n=41 participants at risk
Participants who have been treated with Zyvox (linezolid).
|
|---|---|
|
Investigations
Platelet count decreased
|
24.4%
10/41 • Number of events 10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
3/41 • Number of events 3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
7.3%
3/41 • Number of events 3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Superinfection
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness postural
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal disorder
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Multi-organ failure
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cell count decreased
|
2.4%
1/41 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER