Vancomycin Resistance Enterococcus FaeciumNCT01224626

Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)

An observational study of Vancomycin Resistance Enterococcus Faecium, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Vancomycin Resistance Enterococcus Faecium
What is being tested?: Zyvox (linezolid)
How many people: 41 participants
Where: No sites listed yet
Study dates: May 2006to Apr 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The patients who are prescribed to Zyvox (linezolid).

Who may be able to join

Subject to whom Zyvox (linezolid) was administered.
Infected subject with Vancomycin resistance Enterococcus faecium.

Who cannot join

Infected subject with MRSA and other organism.

About this study

Official title: Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)

Conditions: Vancomycin Resistance Enterococcus Faecium
Being tested: Zyvox (linezolid)
Keywords: VRE, Japanese, Post Marketing Surveillance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zyvox (linezolid)Drug
Also called linezolid, Zyvox
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.

Study groups in NCT01224626
Study group	Role	What they receive
Zyvox (linezolid)		Patients who have been treated with Zyvox (linezolid). Receives: Drug: Zyvox (linezolid)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 8 weeks
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.
Measured: Baseline to 8 weeks

Secondary outcomes (1)

Adverse Drug Reactions Unlisted in Japanese Package Insert.
The adverse drug reactions that have not been included in Japanese package insert.
Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Apr 2011

First posted20 Oct 2010 (estimated)
Study startMay 2006
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vancomycin Resistance Enterococcus FaeciumStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01224626
Sponsor's protocol ID: A5951139
Status last verified: May 2012
First submitted: 18 Oct 2010
Last updated: 2 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT01224626
Acronym / sponsor ID: A5951139
Conditions: Vancomycin Resistance Enterococcus Faecium
Keywords: VRE, Japanese, Post Marketing Surveillance
Study type: Observational
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 20 Oct 2010 (estimated)
Results: Posted 2 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Zyvox (linezolid)	–	Drug: Zyvox (linezolid)Patients who have been treated with Zyvox (linezolid).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patients who are prescribed to Zyvox (linezolid).

Key inclusion criteria (2 listed)

Subject to whom Zyvox (linezolid) was administered.
Infected subject with Vancomycin resistance Enterococcus faecium.

Key exclusion criteria (1 listed)

Infected subject with MRSA and other organism.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zyvox (linezolid)Also: linezolid, ZyvoxPatients should be treated with Zyvox (linezolid) 600 mg every twelve hours.	Drug	Zyvox (linezolid)

Primary outcome

Number of Participants With Adverse Drug Reactions.
Time frame: 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.
Time frame: 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.

1 secondary outcome

Adverse Drug Reactions Unlisted in Japanese Package Insert.
Time frame: Baseline to 8 weeks

Results and safety

Results posted to the registry on 2 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Linezolid	42	41

Primary outcome: Number of Participants With Adverse Drug Reactions.

Time frame: Baseline to 8 weeks. Number. Unit: participants

Measure	Linezolid n = 41
Platelet count decreased	10
Anaemia	3
White blood cell count decreased	3
Superinfection	1
Sepsis	1
Histiocytosis haematophagic	1
Pancytopenia	1
Dizziness postural	1

Population analysed: Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.

Primary outcome: Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.

Time frame: Baseline to 8 weeks. Number. Unit: participants

Measure	Linezolid n = 17
Value	16

Population analysed: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linezolid	9 of 41 (22%)	21 of 41 (51.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Vancomycin Resistance Enterococcus Faecium, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions. (time frame: Baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01224626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.