Methicillin Resistant Staphylococcus Aureus (MRSA)Phase 4ZEPHYRNCT00084266

Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

A Phase 4 study testing linezolid (Zyvox) and vancomycin in people with Methicillin Resistant Staphylococcus Aureus (MRSA), run by Pfizer at 177 sites in 23 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Methicillin Resistant Staphylococcus Aureus (MRSA)
What is being tested?: linezolid (Zyvox) and vancomycin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,225 participants
Where: 177 sitesin 23 countries
Study dates: Oct 2004to Mar 2010
Phase: Phase 4
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

Who may be able to join

Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Who cannot join

Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
Subjects with severe neutropenia (<500 cells/mm3)
Subjects with hypersensitivity to oxazolidinones or vancomycin.

Trial locations and contacts

177 sites in 23 countries.

Country

City, postcode or hospital

177 sites in 23 countries

United States108 sites

Pfizer Investigational Site
Abington, Pennsylvania, 19001
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0331
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Augusta, Georgia, 30912
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18017
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35249
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02118
Pfizer Investigational Site
Brandon, Florida, 33511
Pfizer Investigational Site
Brooklyn, New York, 11215
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0558
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Columbus, Ohio, 43214
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Columbus, Ohio, 43222
Pfizer Investigational Site
Decatur, Georgia, 30030
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Denver, Colorado, 80205
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Detroit, Michigan, 48210
Pfizer Investigational Site
Fargo, North Dakota, 58112
Pfizer Investigational Site
Fargo, North Dakota, 58122
Pfizer Investigational Site
Fort Lauderdale, Florida, 33316
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Greensboro, North Carolina, 27401
Pfizer Investigational Site
Hackensack, New Jersey, 07601
Pfizer Investigational Site
Hazard, Kentucky, 41701
Pfizer Investigational Site
Honolulu, Hawaii, 96817
Pfizer Investigational Site
Houston, Texas, 77030-1608
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Irving, Texas, 75061
Pfizer Investigational Site
Jackson, Florida, 32209
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Las Vegas, Nevada, 89109
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Louisville, Kentucky, 40206
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Montgomery, Alabama, 36111
Pfizer Investigational Site
Murray, Utah, 84157
Pfizer Investigational Site
Nashville, Tennessee, 37232-7110
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New Albany, Indiana, 47151
Pfizer Investigational Site
New York, New York, 10011
Pfizer Investigational Site
New York, New York, 10021-9800
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
Newark, Delaware, 19718
Pfizer Investigational Site
North Chicago, Illinois, 60064
Pfizer Investigational Site
Oak Park, Illinois, 60302-2566
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Orlando, Florida, 32801
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19102
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Portland, Oregon, 97213
Pfizer Investigational Site
Portland, Oregon, 97220
Pfizer Investigational Site
Providence, Rhode Island, 02903
Pfizer Investigational Site
Redlands, California, 92373
Pfizer Investigational Site
Reno, Nevada, 89502
Pfizer Investigational Site
Reno, Nevada, 89503
Pfizer Investigational Site
Richmond, Virginia, 23219
Pfizer Investigational Site
Rochester, New York, 14642-8410
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Sacramento, California, 95817
Pfizer Investigational Site
Saint Loius, Missouri, 63110
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78284
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Francisco, California, 94110
Pfizer Investigational Site
San Marcos, Texas, 78666
Pfizer Investigational Site
Sequin, Texas, 78155
Pfizer Investigational Site
Sioux Falls, South Dakota, 57104
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105
Pfizer Investigational Site
Sioux Falls, South Dakota, 57117-5045
Pfizer Investigational Site
Springfield, Illinois, 62701
Pfizer Investigational Site
Springfield, Illinois, 62702
Pfizer Investigational Site
Springfield, Illinois, 62703
Pfizer Investigational Site
Springfield, Massachusetts, 01199
Pfizer Investigational Site
St Louis, Missouri, 63110-1010
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Sylvania, Ohio, 43560
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
The Bronx, New York, 10457
Pfizer Investigational Site
Toledo, Ohio, 43608
Pfizer Investigational Site
Toledo, Ohio, 43614
Pfizer Investigational Site
Washington D.C., District of Columbia, 20017
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037
Pfizer Investigational Site
Winchester, Virginia, 22601

Other trials in United States

Russia6 sites

Pfizer Investigational Site
Moscow, Russia, 117049
Pfizer Investigational Site
Moscow, 111539
Pfizer Investigational Site
Moscow, 113093
Pfizer Investigational Site
Moscow, 115446
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Moscow, 123448

Other trials in Russia

South Korea5 sites

Pfizer Investigational Site
Seoul, 134-701
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 150-713

Other trials in South Korea

Belgium4 sites

Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Liège, B-4000

Other trials in Belgium

Colombia4 sites

Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Bogotá, Bogota. DC
Pfizer Investigational Site
Ibague, Tolima Department

Other trials in Colombia

France4 sites

Pfizer Investigational Site
Marseille, France, 13915
Pfizer Investigational Site
Paris, Cedex 18, 75877
Pfizer Investigational Site
Paris, 75013
Pfizer Investigational Site
Saint-Etienne, 42055

Other trials in France

Greece4 sites

Pfizer Investigational Site
Athens, 10676
Pfizer Investigational Site
Crete, Greece, 71110
Pfizer Investigational Site
Kifissia, Athens, 14561
Pfizer Investigational Site
Thessaloniki, 57010

Other trials in Greece

Mexico4 sites

Pfizer Investigational Site
Ciudad Madero, Tamaulipas, 89440
Pfizer Investigational Site
Guadalajara, Jalisco, 44280
Pfizer Investigational Site
Mexico City, Mexico City, 14000
Pfizer Investigational Site
Monterrey/Col. Mitras Centro, Nuevo Léon, 64460

Other trials in Mexico

Poland4 sites

Pfizer Investigational Site
Bytom, 41-902
Pfizer Investigational Site
Katowice, 40-752
Pfizer Investigational Site
Krakow, 31 - 066
Pfizer Investigational Site
Krakow, 31-066

Other trials in Poland

Portugal4 sites

Pfizer Investigational Site
Almada, 2800
Pfizer Investigational Site
Coimbra, 3041
Pfizer Investigational Site
Lisbon, 1449-005
Pfizer Investigational Site
Senhora da Hora, 4464-513

Other trials in Portugal

Spain4 sites

Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Barcelona, Barcelona, 08003
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Madrid, Madrid, 28040

Other trials in Spain

Taiwan4 sites

Pfizer Investigational Site
Banqiao District, 220
Pfizer Investigational Site
Kaohsiung City, 813
Pfizer Investigational Site
Taichung, 404
Pfizer Investigational Site
Taipei, 100

Other trials in Taiwan

Brazil3 sites

Pfizer Investigational Site
Salvador, Estado de Bahia, 40420-000
Pfizer Investigational Site
São José do Rio Preto, São Paulo, 15090-000
Pfizer Investigational Site
São Paulo, São Paulo, 05651-901

Other trials in Brazil

Chile3 sites

Pfizer Investigational Site
Santiago, RM
Pfizer Investigational Site
Santiago, Santiago Metropolitan
Pfizer Investigational Site
Santiago

Other trials in Chile

Germany3 sites

Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Leipzig, 04129
Pfizer Investigational Site
Leipzig, 04289

Other trials in Germany

South Africa3 sites

Pfizer Investigational Site
Auckland Park, 2006
Pfizer Investigational Site
Bloefontein, 9301
Pfizer Investigational Site
Soweto, 2013

Other trials in South Africa

Malaysia2 sites

Pfizer Investigational Site
Kuala Lumpur, 50586
Pfizer Investigational Site
Kuala Lumpur, 59100

Other trials in Malaysia

Puerto Rico2 sites

Pfizer Investigational Site
Ponce, 00716
Pfizer Investigational Site
San Juan, 00921-3201

Other trials in Puerto Rico

United Kingdom2 sites

Pfizer Investigational Site
Edinburgh, EH16 4SA
Pfizer Investigational Site
Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Argentina1 site

Pfizer Investigational Site
Buenos Aires, Buenos Aires, 1181

Other trials in Argentina

Hong Kong1 site

Pfizer Investigational Site
Hong Kong

Other trials in Hong Kong

Turkey (Türkiye)1 site

Pfizer Investigational Site
Ankara, 06100

Other trials in Turkey (Türkiye)

Location not given1 site

Pfizer Investigational Site

About this study

Official title: Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

Conditions: Methicillin Resistant Staphylococcus Aureus (MRSA)
Being tested: linezolid (Zyvox), vancomycin
Keywords: Staphylococcal pneumonia, Methicillin-resistant staphylococcal pneumonia, healthcare-associated pneumonia
Medical subject headings: Pneumonia, Staphylococcal, Healthcare-Associated Pneumonia

What participants receive

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

linezolid (Zyvox)Drug
Also called Zyvox, linezolid
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
vancomycinDrug
Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.

Study groups in NCT00084266
Study group	Role	What they receive
1	Experimental	Subjects receiving linezolid for the treatment phase of the study Receives: Drug: linezolid (Zyvox)
2	Active comparator	Subjects receiving vancomycin for the treatment phase of the study Receives: Drug: vancomycin

What is being measured

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

Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
Measured: EOS (7-30 days after last dose)

Secondary outcomes (14)

Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population
Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
Measured: EOS (7-30 days after last dose)
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
Measured: EOT (within 72 hours of last dose)
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.
Measured: EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Measured: EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Measured: EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Measured: EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.
Measured: EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for PP Population
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Measured: EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Measured: EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for PP Population
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Measured: EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population
Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.
Measured: EOT (within 72 hours of last dose)
Survival Status Estimated by Kaplan-Meier Analysis for PP Population
For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
Measured: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Survival Status Estimated by Kaplan-Meier Analysis for mITT Population
For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
Measured: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Survival Status Estimated by Kaplan-Meier Analysis for ITT Population
For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.
Measured: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

Timeline

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

Oct 2004Mar 2010

First posted11 Jun 2004 (estimated)
Study startOct 2004
Primary completionMar 2010
Study completionMar 2010

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Methicillin Resistant Staphylococcus Aureus (MRSA)Studies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00084266
Sponsor's protocol ID: A5951001
Acronym: ZEPHYR
Status last verified: Jan 2012
First submitted: 9 Jun 2004
Last updated: 1 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Equils O, da Costa C, Wible M, Lipsky BA. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin. BMC Infect Dis. 2016 Sep 6;16(1):476. doi: 10.1186/s12879-016-1779-5.
PubMed 27600290
Shorr AF, Puzniak LA, Biswas P, Niederman MS. Predictors of Clinical Success in the Treatment of Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) Nosocomial Pneumonia (NP). PLoS One. 2015 Jul 21;10(7):e0131932. doi: 10.1371/journal.pone.0131932. eCollection 2015.
PubMed 26196695
Quartin AA, Scerpella EG, Puttagunta S, Kett DH. A comparison of microbiology and demographics among patients with healthcare-associated, hospital-acquired, and ventilator-associated pneumonia: a retrospective analysis of 1184 patients from a large, international study. BMC Infect Dis. 2013 Nov 27;13:561. doi: 10.1186/1471-2334-13-561.
PubMed 24279701
Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.
PubMed 24011955

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
ClinicalTrials.gov ID: NCT00084266
Acronym / sponsor ID: ZEPHYR / A5951001
Conditions: Methicillin Resistant Staphylococcus Aureus (MRSA)
Keywords: Staphylococcal pneumonia, Methicillin-resistant staphylococcal pneumonia, healthcare-associated pneumonia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,225 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 11 Jun 2004 (estimated)
Results: Posted 9 May 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: linezolid (Zyvox)Subjects receiving linezolid for the treatment phase of the study
2	Active comparator	Drug: vancomycinSubjects receiving vancomycin for the treatment phase of the study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Key exclusion criteria (3 listed)

Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
Subjects with severe neutropenia (<500 cells/mm3)
Subjects with hypersensitivity to oxazolidinones or vancomycin.

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)Also: Zyvox, linezolidSubjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.	Drug	1
vancomycinSubjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.	Drug	2

Primary outcome

Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
Time frame: EOS (7-30 days after last dose)
Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.

14 secondary outcomes

Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population
Time frame: EOS (7-30 days after last dose)
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Time frame: EOT (within 72 hours of last dose)
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Time frame: EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Time frame: EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Time frame: EOS (7-30 days after last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Time frame: EOT (within 72 hours of last dose)
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Time frame: EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for PP Population
Time frame: EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population
Time frame: EOS (7-30 days after last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for PP Population
Time frame: EOT (within 72 hours of last dose)
Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population
Time frame: EOT (within 72 hours of last dose)
Survival Status Estimated by Kaplan-Meier Analysis for PP Population
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Survival Status Estimated by Kaplan-Meier Analysis for mITT Population
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.
Survival Status Estimated by Kaplan-Meier Analysis for ITT Population
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

Results and safety

Results posted to the registry on 9 May 2011, 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	618	177
Vancomycin	607	184

Primary outcome: Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population

Time frame: EOS (7-30 days after last dose). Number. Unit: Participants

Measure	Linezolid n = 165	Vancomycin n = 174
Cure	95	81
Failure	70	93
Unknown/Missing (excluded from analysis)	7	2

Linezolid vs Vancomycin: p = 0.042, Chi-squared

Population analysed: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.

14 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	145 of 597 (24.3%)	348 of 597 (58.3%)	Not reported
Vancomycin	141 of 587 (24%)	381 of 587 (64.9%)	Not reported

Limitations and caveats (from the sponsor): EOS visit window of 15-21 days after last dose as specified in protocol was expanded during blinded evaluability assessments and prior to database lock and unblinding to 7-30 days after last dose in order to better fit the actual study visit days.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27600290Equils O, da Costa C, Wible M, Lipsky BA. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin. BMC Infect Dis. 2016 Sep 6;16(1):476. doi: 10.1186/s12879-016-1779-5.
Derived from this study: PubMed 26196695Shorr AF, Puzniak LA, Biswas P, Niederman MS. Predictors of Clinical Success in the Treatment of Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) Nosocomial Pneumonia (NP). PLoS One. 2015 Jul 21;10(7):e0131932. doi: 10.1371/journal.pone.0131932. eCollection 2015.
Derived from this study: PubMed 24279701Quartin AA, Scerpella EG, Puttagunta S, Kett DH. A comparison of microbiology and demographics among patients with healthcare-associated, hospital-acquired, and ventilator-associated pneumonia: a retrospective analysis of 1184 patients from a large, international study. BMC Infect Dis. 2013 Nov 27;13:561. doi: 10.1186/1471-2334-13-561.
Derived from this study: PubMed 24011955Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.

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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

177 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing linezolid (Zyvox) and vancomycin in people with Methicillin Resistant Staphylococcus Aureus (MRSA), run by Pfizer at 177 sites in 23 countries.

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 3 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 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Russia, South Korea, Belgium, Colombia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2011). 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?

Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population (time frame: EOS (7-30 days after last dose)). 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 NCT00084266, which also lists 4 linked publications.

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 1 Feb 2012.