Skin/Soft Tissue InfectionsPhase 4NCT00087490
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
A Phase 4 study testing linezolid and vancomycin in people with Skin/Soft Tissue Infections and Methicillin Resistant Staphylococcus Aureus (MRSA), run by Pfizer at 126 sites in 16 countries.
Trial summary
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin/Soft Tissue Infections, Methicillin Resistant Staphylococcus Aureus (MRSA)
- What is being tested?
- linezolid and vancomycin
- How many people
- 1,077 participants
- Where
- 126 sitesin 16 countries
- Study dates
- Oct 2004to Jul 2007
- 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
- Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
- Signs and symptoms consistent with infection
- Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus
Who cannot join
- Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
- Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
- Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
Trial locations and contacts
126 sites in 16 countries.
126 sites in 16 countries
United States76 sites
Pfizer Investigational Site
Akron, Ohio, 44304
Pfizer Investigational Site
Akron, Ohio, 44309
Pfizer Investigational Site
Akron, Ohio, 44310
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlantis, Florida, 33462
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21230
Pfizer Investigational Site
Baltimore, Maryland, 21237
Pfizer Investigational Site
Blue Ridge, Georgia, 30513
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Butte, Montana, 59701
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Columbus, Ohio, 43214
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Dallas, Texas, 75390-9016
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Decatur, Illinois, 62526
Pfizer Investigational Site
Denver, Colorado, 80205
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Ducktown, Tennessee, 37326
Pfizer Investigational Site
East Lansing, Michigan, 48824
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Forth Worth, Texas, 76104
Pfizer Investigational Site
Hartford, Connecticut, 06102
Pfizer Investigational Site
Hartford, Connecticut, 06106
Pfizer Investigational Site
Hines, Illinois, 60141
Pfizer Investigational Site
Honolulu, Hawaii, 96813
Pfizer Investigational Site
Honolulu, Hawaii, 96817
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Jackson, Tennessee, 38301
Pfizer Investigational Site
Lansing, Michigan, 48912
Pfizer Investigational Site
Lincoln, Nebraska, 46851
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Louisville, Kentucky, 40202-1798
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Louisville, Kentucky, 40222
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Minneapolis, Minnesota, 55422-2998
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Mpls, Minnesota, 55422
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New Haven, Connecticut, 06515
Pfizer Investigational Site
New Orleans, Louisiana, 70121
Pfizer Investigational Site
North Chicago, Illinois, 60064
Pfizer Investigational Site
Northlake, Illinois, 60164
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Pensacola, Florida, 32501-6390
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141
Pfizer Investigational Site
Rancho Mirage, California, 92270
Pfizer Investigational Site
Saint Paul, Minnesota, 55101
Pfizer Investigational Site
San Pedro, California, 90732
Pfizer Investigational Site
Santa Fe Springs, California, 90670
Pfizer Investigational Site
Somers Point, New Jersey, 08244
Pfizer Investigational Site
Springfield, Illinois, 62701
Pfizer Investigational Site
Springfield, Illinois, 62702
Pfizer Investigational Site
St. George, Utah, 84770
Pfizer Investigational Site
St. George, Utah, 84790
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Sylmar, California, 91342
Pfizer Investigational Site
Tacoma, Washington, 98431
Pfizer Investigational Site
Toledo, Ohio, 43608
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Torrance, California, 90503
Pfizer Investigational Site
Torrance, California, 90509
Pfizer Investigational Site
Tucson, Arizona, 85723
Pfizer Investigational Site
West Reading, Pennsylvania, 19611
Pfizer Investigational Site
West Roxbury, Massachusetts, 02132
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Italy6 sites
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Roma, 00149
Pfizer Investigational Site
Roma, 00168
Pfizer Investigational Site
Udine, 33100
Pfizer Investigational Site
Varese, 21100
Portugal5 sites
Pfizer Investigational Site
Amadora, 2720
Pfizer Investigational Site
Coimbra, 3090
Pfizer Investigational Site
Lisbon, 1449-005
Pfizer Investigational Site
Lisbon
Pfizer Investigational Site
Pragal, Almada, 2800-525
South Africa5 sites
Pfizer Investigational Site
Johannesburg, 2113
Pfizer Investigational Site
Kuilsriver, Western Province, 7580
Pfizer Investigational Site
Parow, 7499
Pfizer Investigational Site
Pretoria, 0001
Pfizer Investigational Site
Pretoria, 0184
Venezuela5 sites
Pfizer Investigational Site
Ciudad Bolívar, Bolívar, 8001
Pfizer Investigational Site
Distrito Capital, Miranda, 1040
Pfizer Investigational Site
Distrito Capital, Miranda, 1070
Pfizer Investigational Site
Maracaibo, Zulia, 4002
Pfizer Investigational Site
Valencia, Valencia, 2002
Argentina4 sites
Pfizer Investigational Site
Buenos Aires, Buenos Aires, C1039AAO
Pfizer Investigational Site
Buenos Aires, C1425DQK
Pfizer Investigational Site
Córdoba, 5000
Pfizer Investigational Site
Loma Hermosa, Buenos Aires, 1653
Belgium3 sites
Pfizer Investigational Site
Charleroi, 6000
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Montigny-le-Tilleul, 6110
Colombia3 sites
Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Floridablanca, Santander Department
Mexico3 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44280
Pfizer Investigational Site
Mexico City, Mexico City, 14000
Pfizer Investigational Site
Monterrey, Nuevo León, 64020
Russia3 sites
Pfizer Investigational Site
Moscow, 119048
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Smolensk
Spain3 sites
Pfizer Investigational Site
Córdoba, Cordoba, 14004
Pfizer Investigational Site
Girona, Gerona, 17007
Pfizer Investigational Site
Seville, Sevilla, 41013
United Kingdom3 sites
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
Leeds, LS1 3EX
Pfizer Investigational Site
Winchester, Hampshire, SO22 5DG
Brazil2 sites
Pfizer Investigational Site
São José do Rio Preto, São Paulo, 15090-000
Pfizer Investigational Site
São Paulo, São Paulo, 01221-020
Chile2 sites
Pfizer Investigational Site
Providencia, Santiago Metropolitan
Pfizer Investigational Site
Santiago
Malaysia2 sites
Pfizer Investigational Site
Kuala Lumpur, 50586
Pfizer Investigational Site
Kuala Lumpur, 50603
About this study
Official title: Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
- Being tested
- linezolid, vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linezolidDrug
vancomycinDrug
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 Per-Protocol (PP) Population
Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
Measured: EOS (6 to 28 days after the last dose of study drug)
Secondary outcomes (14)
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.
Measured: EOT (within 72 hours of last dose of study drug)
Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population
CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs/symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
Measured: EOS (6 to 28 days after the last dose of study drug)
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.
Measured: EOT (within 72 hours of last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).
Measured: EOS (6 to 28 days after the last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).
Measured: EOT (within 72 hours of last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).
Measured: EOS (6 to 28 days after the last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).
Measured: EOT (within 72 hours of last dose of study drug)
Number of Participants With Clinical Signs and Symptoms at EOT and 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 of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".
Measured: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
Number of Participants With Clinical Signs and Symptoms at EOT and 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 of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".
Measured: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
Duration of Hospital Stay for PP Population
Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.
Measured: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Duration of Hospital Stay for mITT Population
Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.
Measured: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Duration of Intravenous Therapy for PP Population
Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Measured: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Duration of Intravenous Therapy for mITT Population
Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Measured: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Number of Participants Using Medical Resources
Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.
Measured: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2004 (estimated)
- Study startOct 2004
- Primary completionJul 2007
- Study completionJul 2007
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 (2)Papers the sponsor has linked to this study.
- Other trials for Skin/Soft Tissue 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087490
- Sponsor's protocol ID
- A5951002
- Status last verified
- Jun 2012
- First submitted
- 9 Jul 2004
- Last updated
- 8 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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 24011955Itani KM, Biswas P, Reisman A, Bhattacharyya H, Baruch AM. Clinical efficacy of oral linezolid compared with intravenous vancomycin for the treatment of methicillin-resistant Staphylococcus aureus-complicated skin and soft tissue infections: a retrospective, propensity score-matched, case-control analysis. Clin Ther. 2012 Aug;34(8):1667-73.e1. doi: 10.1016/j.clinthera.2012.06.018. Epub 2012 Jul 6.
PubMed 22770644
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT00087490
- Acronym / sponsor ID
- A5951002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Jul 2004 (estimated)
- Results
- Posted 8 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
- Signs and symptoms consistent with infection
- Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus
Key exclusion criteria (3 listed)
- Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
- Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
- Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
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 | Drug | – |
| vancomycin | Drug | – |
Primary outcome
Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population
Time frame: EOS (6 to 28 days after the last dose of study drug)
Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
14 secondary outcomes
Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
Time frame: EOT (within 72 hours of last dose of study drug)
Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population
Time frame: EOS (6 to 28 days after the last dose of study drug)
Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
Time frame: EOT (within 72 hours of last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
Time frame: EOS (6 to 28 days after the last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
Time frame: EOT (within 72 hours of last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
Time frame: EOS (6 to 28 days after the last dose of study drug)
Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
Time frame: EOT (within 72 hours of last dose of study drug)
Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population
Time frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population
Time frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
Duration of Hospital Stay for PP Population
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Duration of Hospital Stay for mITT Population
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Duration of Intravenous Therapy for PP Population
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Duration of Intravenous Therapy for mITT Population
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Number of Participants Using Medical Resources
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 22770644Itani KM, Biswas P, Reisman A, Bhattacharyya H, Baruch AM. Clinical efficacy of oral linezolid compared with intravenous vancomycin for the treatment of methicillin-resistant Staphylococcus aureus-complicated skin and soft tissue infections: a retrospective, propensity score-matched, case-control analysis. Clin Ther. 2012 Aug;34(8):1667-73.e1. doi: 10.1016/j.clinthera.2012.06.018. Epub 2012 Jul 6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
126 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing linezolid and vancomycin in people with Skin/Soft Tissue Infections and Methicillin Resistant Staphylococcus Aureus (MRSA), run by Pfizer at 126 sites in 16 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 126 sites in United States, Italy, Portugal, South Africa, Venezuela and 11 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 8 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?
Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population (time frame: EOS (6 to 28 days after the last dose of study drug)). 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 NCT00087490, which also lists 2 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 8 Aug 2012.