Gram-Positive Bacterial InfectionsA5951090NCT01564758

Post Marketing Surveillance Study on Linezolid

An observational study of Gram-Positive Bacterial Infections, run by Pfizer.

Completed

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

Trial summary

The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gram-Positive Bacterial Infections
What is being tested?: Linezolid
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 99 participants
Where: No sites listed yet
Study dates: Feb 2004to Mar 2005
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult, Filipino patients diagnosed with gram positive infection

Who may be able to join

Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
Male or female, 18 years old and above

Who cannot join

Known hypersensitivity
Subjects diagnosed with pure gram-negative infection

About this study

Official title: Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections

The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

Read the detailed description

The subjects were identified after the physician decided to prescribed the drug to the subject.

Conditions: Gram-Positive Bacterial Infections
Being tested: Linezolid
Keywords: non-interventional, non-comparative, open-label study, safety, Linezolid, gram positive infections, Filipino
Medical subject headings: Gram-Positive Bacterial Infections

What participants receive

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

LinezolidDrug
1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days
2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days
3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days

Study groups in NCT01564758
Study group	Role	What they receive
Group 1		Subjects that are diagnosed with gram positive infection Receives: Drug: Linezolid

What is being measured

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

Number of Participants With Adverse Events (AEs)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.
Measured: Baseline up to End of Treatment (EOT) (Day 10 up to 28)

Secondary outcomes (1)

Number of Participants With Clinical Response
Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.
Measured: EOT (Day 10 up to 28)

Timeline

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

Feb 2004Mar 2005

First posted28 Mar 2012 (estimated)
Study startFeb 2004
Primary completionMar 2005
Study completionMar 2005

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 Gram-Positive Bacterial 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: Cohort
Time perspective: Prospective
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01564758
Sponsor's protocol ID: A5951090
Other IDs: GRAM POSITIVE INFECTIONS
Acronym: A5951090
Status last verified: Jun 2012
First submitted: 26 Mar 2012
Last updated: 6 Aug 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

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All Gram-Positive Bacterial Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections
ClinicalTrials.gov ID: NCT01564758
Acronym / sponsor ID: A5951090 / A5951090
Conditions: Gram-Positive Bacterial Infections
Keywords: non-interventional, non-comparative, open-label study, safety, Linezolid, gram positive infections, Filipino
Study type: Observational
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Mar 2005 (actual)
Study completion: Mar 2005 (actual)
First posted: 28 Mar 2012 (estimated)
Results: Posted 6 Aug 2012

Clinical summary

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

The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

Detailed description

The subjects were identified after the physician decided to prescribed the drug to the subject.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Group 1	–	Drug: LinezolidSubjects that are diagnosed with gram positive infection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult, Filipino patients diagnosed with gram positive infection

Key inclusion criteria (2 listed)

Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
Male or female, 18 years old and above

Key exclusion criteria (2 listed)

Known hypersensitivity
Subjects diagnosed with pure gram-negative infection

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
Linezolid1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days 2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days 3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days	Drug	Group 1

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to End of Treatment (EOT) (Day 10 up to 28)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.

1 secondary outcome

Number of Participants With Clinical Response
Time frame: EOT (Day 10 up to 28)

Results and safety

Results posted to the registry on 6 Aug 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	99	85

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Baseline up to End of Treatment (EOT) (Day 10 up to 28). Number. Unit: participants

Measure	Linezolid n = 99
Value	15

Population analysed: Safety analysis set included all the participants who received at least 1 dose of study medication.

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	10 of 99 (10.1%)	5 of 99 (5.1%)	Not reported

Limitations and caveats (from the sponsor): Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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.

Related trials for Gram-Positive Bacterial Infections

RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection

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 Gram-Positive Bacterial 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 2 inclusion and 2 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 6 Aug 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 6 Aug 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 Events (AEs) (time frame: Baseline up to End of Treatment (EOT) (Day 10 up to 28)). 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 NCT01564758.

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 6 Aug 2012.