Staphylococcal InfectionsNCT00666276

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

An observational study of Staphylococcal Infections, run by Pfizer.

Completed

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

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Staphylococcal Infections
What is being tested?: linezolid (Zyvox)
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 1,004 participants
Where: No sites listed yet
Study dates: Feb 2007to 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 whom an investigator involving A5951142 prescribes the Linezolid.

Who may be able to join

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

Who cannot join

Patients not administered Linezolid.

About this study

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.

Read the 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.

Conditions: Staphylococcal Infections
Being tested: linezolid (Zyvox)
Medical subject headings: Staphylococcal Infections

What participants receive

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

linezolid (Zyvox)Drug
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.

Study groups in NCT00666276
Study group	Role	What they receive
linezolid (Zyvox)		Patients taking Linezolid. Receives: Drug: linezolid (Zyvox)

What is being measured

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

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

Timeline

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

Feb 2007Apr 2011

First posted24 Apr 2008 (estimated)
Study startFeb 2007
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 Staphylococcal InfectionsStudies 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: Prospective
Enrolment: 1,004 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666276
Sponsor's protocol ID: A5951142
Status last verified: May 2012
First submitted: 22 Apr 2008
Last updated: 2 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC

All Staphylococcal Infections trials

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: Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT00666276
Acronym / sponsor ID: A5951142
Conditions: Staphylococcal Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 1,004 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 24 Apr 2008 (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.

Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection disease.

Detailed description

Study design

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

Arm	Type	Receives
linezolid (Zyvox)	–	Drug: linezolid (Zyvox)Patients taking Linezolid.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patients whom an investigator involving A5951142 prescribes the Linezolid.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Patients not administered Linezolid.

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
linezolid (Zyvox)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.	Drug	linezolid (Zyvox)

Primary outcome

Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.

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	1,004	970

Primary outcome: Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.

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

Measure	Linezolid n = 970
Superinfection	1
Sepsis	1
Thrombocytopenia	1
Lactic acidosis	1
Agitation	1
Deep vein thrombosis	1
Hyperbilirubinaemia	1
Antithrombin III decreased	1

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

Primary outcome: Number of Participants With Adverse Drug Reactions(ADRs).

Time frame: 8 weeks. Number. Unit: participants

Measure	Linezolid n = 970
Value	163

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

Primary outcome: Factors Considered to Affect the Safety of Linezolid - Gender.

Time frame: 8 weeks. Number. Unit: participants

Measure	Linezolid-male n = 662	Linezolid-female n = 308
Value	109	54

Linezolid-male vs Linezolid-female: p =0.712, Fisher Exact

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

Primary outcome: Factors Considered to Affect the Safety of Linezolid - Age

Time frame: 8 weeks. Number. Unit: participants

Measure	Linezolid-over 65 n = 688	Linezolid-less Than 65 n = 282
Value	122	41

Linezolid-over 65: p =0.257, Fisher Exact

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

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linezolid	50 of 970 (5.2%)	163 of 970 (16.8%)	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.

Related trials for Staphylococcal Infections

RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC

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 Staphylococcal Infections, 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 1 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 Reaction Not Expected From the Japanese Package Insert. (time frame: Baseline to 8 weeks). The study lists 11 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 NCT00666276.

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.