PneumoniaNCT01819935

Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia

An observational study of Pneumonia, 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 non-interventional, retrospective study of existing data is to evaluate clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based pneumonia by treatment and among subpopulations. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Pneumonia
What is being tested?: linezolid (Zyvox) and vancomycin
How many people: 5,271 participants
Where: No sites listed yet
Study dates: Dec 2012to Jan 2013
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010

Who may be able to join

MRSA and pneumonia cases by ICD-9 code identification.
Diagnosis included during inpatient stay.
Treatment initiation in hospital.

Who cannot join

Death of discharge within 3 days of treatment initiation.
Exposure to other treatments with MRSA activity.

About this study

Official title: Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin

Read the detailed description

All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.

Conditions: Pneumonia
Being tested: linezolid (Zyvox), vancomycin
Keywords: MRSA. pneumonia, outcomes
Medical subject headings: Pneumonia

What participants receive

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

linezolid (Zyvox)Drug
As prescribed-this is retrospective cohort of existing clinical data.
vancomycinDrug
As prescribed-this is retrospective cohort of existing clinical data.

Study groups in NCT01819935
Study group	Role	What they receive
linezolid (Zyvox)		Not described Receives: Drug: linezolid (Zyvox)
Vancomycin		Not described Receives: Drug: vancomycin

What is being measured

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

Time to 30-day Mortality
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)

Secondary outcomes (7)

Time to Therapy Change
Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Discharge From the Hospital
Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Transfer Out From the Intensive Care Unit (ICU)
Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Intubation
Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to 30-day Re-admission
Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection
Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Clinical Success
Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.
Measured: Baseline (1 January 2001) up to 3559 Days (30 September 2010)

Timeline

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

Dec 2012Jan 2013

First posted28 Mar 2013 (estimated)
Study startDec 2012
Primary completionJan 2013
Study completionJan 2013

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 PneumoniaStudies 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: Retrospective
Enrolment: 5,271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01819935
Sponsor's protocol ID: A5951163
Status last verified: Dec 2013
First submitted: 28 Feb 2013
Last updated: 30 Jan 2014
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 Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin
ClinicalTrials.gov ID: NCT01819935
Acronym / sponsor ID: A5951163
Conditions: Pneumonia
Keywords: MRSA. pneumonia, outcomes
Study type: Observational
Recruitment status: Completed
Enrolment: 5,271 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 28 Mar 2013 (estimated)
Results: Posted 30 Jan 2014

Clinical summary

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

Detailed description

All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
linezolid (Zyvox)	–	Drug: linezolid (Zyvox)
Vancomycin	–	Drug: vancomycin

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010

Key inclusion criteria (3 listed)

MRSA and pneumonia cases by ICD-9 code identification.
Diagnosis included during inpatient stay.
Treatment initiation in hospital.

Key exclusion criteria (2 listed)

Death of discharge within 3 days of treatment initiation.
Exposure to other treatments with MRSA activity.

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)As prescribed-this is retrospective cohort of existing clinical data.	Drug	linezolid (Zyvox)
vancomycinAs prescribed-this is retrospective cohort of existing clinical data.	Drug	Vancomycin

Primary outcome

Time to 30-day Mortality
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.

7 secondary outcomes

Time to Therapy Change
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Discharge From the Hospital
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Transfer Out From the Intensive Care Unit (ICU)
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Intubation
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to 30-day Re-admission
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Clinical Success
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)

Results and safety

Results posted to the registry on 30 Jan 2014, 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	328	328
Vancomycin	4,943	4,943

Primary outcome: Time to 30-day Mortality

Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010). Median (Full Range). Unit: days

Measure	Linezolid n = 328	Vancomycin n = 4943
Value	15 (3 to 30)	14 (3 to 30)

Linezolid vs Vancomycin: Hazard Ratio (HR): 0.93 (95% CI 0.72 to 1.20)

Population analysed: FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.

7 secondary outcomes are 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	0 of 0	0 of 0	Not reported
Vancomycin	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Results for 'time to intubation' was reported and not 'time to extubation' due to change in planned analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
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.

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Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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Enrolling by invitation
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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 Pneumonia, 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 3 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 30 Jan 2014. 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 30 Jan 2014). 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?

Time to 30-day Mortality (time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)). 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 NCT01819935.

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 30 Jan 2014.