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

Condition(s) targeted: Pneumonia, Staphylococcal

Intervention: linezolid (Drug); vancomycin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to 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.

Official title: Linezolid in the Treatment of Subjects With Nosocomial Pneumonia Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults

Secondary outcome: To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Buenos Aires 1181, Argentina; Terminated

Pfizer Investigational Site, Brussels 1070, Belgium; Completed

Pfizer Investigational Site, Gent 9000, Belgium; Completed

Pfizer Investigational Site, LIEGE 1 B-4000, Belgium; Completed

Pfizer Investigational Site, Brugge 8000, Belgium; Completed

Pfizer Investigational Site, Santiago, Chile; Completed

Pfizer Investigational Site, Saint Etienne Cedex 02 42055, France; Recruiting

Pfizer Investigational Site, Paris 75013, France; Recruiting

Pfizer Investigational Site, Marseille Cedex 20 13915, France; Recruiting

Pfizer Investigational Site, Goettingen 37075, Germany; Terminated

Pfizer Investigational Site, Leipzig 04289, Germany; Terminated

Pfizer Investigational Site, Leipzig 04129, Germany; Terminated

Pfizer Investigational Site, Thessaloniki 57010, Greece; Terminated

Pfizer Investigational Site, Crete 71110, Greece; Completed

Pfizer Investigational Site, Athens 10676, Greece; Completed

Pfizer Investigational Site, Hong Kong, Hong Kong; Terminated

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 134-701, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 136-705, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of; Recruiting

Pfizer Investigational Site, Seoul 150-713, Korea, Republic of; Completed

Pfizer Investigational Site, Kuala Lumpur 59100, Malaysia; Completed

Pfizer Investigational Site, Kuala Lumpur 50586, Malaysia; Completed

Pfizer Investigational Site, Bytom 41-902, Poland; Recruiting

Pfizer Investigational Site, Katowice 40-752, Poland; Recruiting

Pfizer Investigational Site, Krakow 31 - 066, Poland; Recruiting

Pfizer Investigational Site, Krakow 31-066, Poland; Recruiting

Pfizer Investigational Site, Coimbra 3041, Portugal; Completed

Pfizer Investigational Site, Almada 2800, Portugal; Terminated

Pfizer Investigational Site, Senhora da Hora 4464-513, Portugal; Completed

Pfizer Investigational Site, Lisboa 1449-005, Portugal; Completed

Pfizer Investigational Site, San Juan 00921-3201, Puerto Rico; Recruiting

Pfizer Investigational Site, Ponce 00716, Puerto Rico; Terminated

Pfizer Investigational Site, Moscow 115446, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 111539, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 113093, Russian Federation; Terminated

Pfizer Investigational Site, Moscow 123448, Russian Federation; Terminated

Pfizer Investigational Site, Moscow 115478, Russian Federation; Recruiting

Pfizer Investigational Site, Unknown, Singapore; Recruiting

Pfizer Investigational Site, Auckland Park 2006, South Africa; Terminated

Pfizer Investigational Site, Soweto 2013, South Africa; Terminated

Pfizer Investigational Site, Bloefontein 9301, South Africa; Terminated

Pfizer Investigational Site, Barcelona 08003, Spain; Completed

Pfizer Investigational Site, Barcelona 08036, Spain; Completed

Pfizer Investigational Site, MADRID 28040, Spain; Terminated

Pfizer Investigational Site, Taichung 404, Taiwan; Recruiting

Pfizer Investigational Site, Taipei 100, Taiwan; Completed

Pfizer Investigational Site, Kaohsiung 813, Taiwan; Recruiting

Pfizer Investigational Site, Pan-Chiao 220, Taiwan; Recruiting

Pfizer Investigational Site, Ankara 06100, Turkey; Completed

Pfizer Investigational Site, Edinburgh EH16 4SA, United Kingdom; Completed

Pfizer Investigational Site, Montgomery, Alabama 36106, United States; Terminated

Pfizer Investigational Site, Montgomery, Alabama 36111, United States; Terminated

Pfizer Investigational Site, Birmingham, Alabama 35249, United States; Not yet recruiting

Pfizer Investigational Site, Birmingham, Alabama 35294, United States; Not yet recruiting

Pfizer Investigational Site, Huntsville, Alabama 35801, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85013, United States; Terminated

Pfizer Investigational Site, Scottsdale, Arizona 85260, United States; Recruiting

Pfizer Investigational Site, Kifisia, Athens 14561, Greece; Terminated

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia; Completed

Pfizer Investigational Site, Salvador, BA 40420-000, Brazil; Completed

Pfizer Investigational Site, BADALONA, BARCELONA 08916, Spain; Completed

Pfizer Investigational Site, Bogota, Bogota. DC, Colombia; Terminated

Pfizer Investigational Site, Redlands, California 92373, United States; Terminated

Pfizer Investigational Site, Los Angeles, California 90033, United States; Recruiting

Pfizer Investigational Site, Orange, California 92868, United States; Recruiting

Pfizer Investigational Site, San Diego, California 92120, United States; Terminated

Pfizer Investigational Site, San Francisco, California 94110, United States; Recruiting

Pfizer Investigational Site, Sacramento, California 95817, United States; Recruiting

Pfizer Investigational Site, San Diego, California 92123, United States; Recruiting

Pfizer Investigational Site, Oceanside, California 92056, United States; Not yet recruiting

Pfizer Investigational Site, Paris, Cedex 18 75877, France; Completed

Pfizer Investigational Site, Denver, Colorado 80205, United States; Recruiting

Pfizer Investigational Site, Denver, Colorado 80218, United States; Recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Completed

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Terminated

Pfizer Investigational Site, Mexico, DF 14000, Mexico; Completed

Pfizer Investigational Site, Newark, Delaware 19718, United States; Recruiting

Pfizer Investigational Site, Plymouth, Devon PL6 8DH, United Kingdom; Recruiting

Pfizer Investigational Site, Washington, District of Columbia 20037, United States; Terminated

Pfizer Investigational Site, Washington, District of Columbia 20010, United States; Not yet recruiting

Pfizer Investigational Site, Washington, District of Columbia 20017, United States; Recruiting

Pfizer Investigational Site, Brandon, Florida 33511, United States; Terminated

Pfizer Investigational Site, Fort Lauderdale, Florida 33316, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33136, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33607, United States; Terminated

Pfizer Investigational Site, Jackson, Florida 32209, United States; Terminated

Pfizer Investigational Site, Jacksonville, Florida 32209, United States; Terminated

Pfizer Investigational Site, Orlando, Florida 32801, United States; Recruiting

Pfizer Investigational Site, Orlando, Florida 32806, United States; Recruiting

Pfizer Investigational Site, Gainesville, Florida 32610, United States; Recruiting

Pfizer Investigational Site, Weston, Florida 33331, United States; Recruiting

Pfizer Investigational Site, Augusta, Georgia 30909, United States; Terminated

Pfizer Investigational Site, Augusta, Georgia 30912, United States; Terminated

Pfizer Investigational Site, Decatur, Georgia 30030, United States; Not yet recruiting

Pfizer Investigational Site, Decatur, Georgia 30033, United States; Not yet recruiting

Pfizer Investigational Site, Honolulu, Hawaii 96817, United States; Recruiting

Pfizer Investigational Site, Springfield, Illinois 62701, United States; Recruiting

Pfizer Investigational Site, Springfield, Illinois 62702, United States; Recruiting

Pfizer Investigational Site, Springfield, Illinois 62703, United States; Recruiting

Pfizer Investigational Site, North Chicago, Illinois 60064, United States; Terminated

Pfizer Investigational Site, Oak Park, Illinois 60302-2566, United States; Terminated

Pfizer Investigational Site, Chicago, Illinois 60612, United States; Not yet recruiting

Pfizer Investigational Site, New Albany, Indiana 47151, United States; Recruiting

Pfizer Investigational Site, Guadalajara, Jalisco 44280, Mexico; Completed

Pfizer Investigational Site, Louisville, Kentucky 40202, United States; Recruiting

Pfizer Investigational Site, Louisville, Kentucky 40206, United States; Recruiting

Pfizer Investigational Site, Lexington, Kentucky 40536, United States; Recruiting

Pfizer Investigational Site, Hazard, Kentucky 41701, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21201, United States; Terminated

Pfizer Investigational Site, Springfield, Massachusetts 01199, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02111, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02118, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02115, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02114, United States; Terminated

Pfizer Investigational Site, Detroit, Michigan 48201, United States; Terminated

Pfizer Investigational Site, Detroit, Michigan 48210, United States; Terminated

Pfizer Investigational Site, Detroit, Michigan 48202, United States; Terminated

Pfizer Investigational Site, Ann Arbor, Michigan 48109-0331, United States; Terminated

Pfizer Investigational Site, St. Loius, Missouri 63110, United States; Recruiting

Pfizer Investigational Site, Saint Louis, Missouri 63110-1010, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63110, United States; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68131, United States; Recruiting

Pfizer Investigational Site, Reno, Nevada 89502, United States; Recruiting

Pfizer Investigational Site, Reno, Nevada 89503, United States; Recruiting

Pfizer Investigational Site, Hackensack, New Jersey 07601, United States; Terminated

Pfizer Investigational Site, New York, New York 10011, United States; Recruiting

Pfizer Investigational Site, Buffalo, New York 14215, United States; Terminated

Pfizer Investigational Site, New York, New York 10021-9800, United States; Terminated

Pfizer Investigational Site, Albany, New York 12208, United States; Terminated

Pfizer Investigational Site, Rochester, New York 14642, United States; Recruiting

Pfizer Investigational Site, Rochester, New York 14642-8410, United States; Terminated

Pfizer Investigational Site, Brooklyn, New York 11215, United States; Terminated

Pfizer Investigational Site, Bronx, New York 10457, United States; Recruiting

Pfizer Investigational Site, New York, New York 10029, United States; Terminated

Pfizer Investigational Site, Stony Brook, New York 11794, United States; Not yet recruiting

Pfizer Investigational Site, Buffalo, New York 14215, United States; Recruiting

Pfizer Investigational Site, Greensboro, North Carolina 27401, United States; Recruiting

Pfizer Investigational Site, Fargo, North Dakota 58112, United States; Recruiting

Pfizer Investigational Site, Fargo, North Dakota 58122, United States; Recruiting

Pfizer Investigational Site, Monterrey/Col. Mitras Centro, Nuevo Léon 64460, Mexico; Completed

Pfizer Investigational Site, Toledo, Ohio 43614, United States; Terminated

Pfizer Investigational Site, Columbus, Ohio 43210, United States; Terminated

Pfizer Investigational Site, Columbus, Ohio 43214, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43215, United States; Recruiting

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States; Terminated

Pfizer Investigational Site, Cincinnati, Ohio 45267-0558, United States; Terminated

Pfizer Investigational Site, Columbus, Ohio 43222, United States; Recruiting

Pfizer Investigational Site, Toledo, Ohio 43608, United States; Recruiting

Pfizer Investigational Site, Portland, Oregon 97213, United States; Recruiting

Pfizer Investigational Site, Portland, Oregon 97220, United States; Recruiting

Pfizer Investigational Site, Allentown, Pennsylvania 18103, United States; Terminated

Pfizer Investigational Site, Bethlehem, Pennsylvania 18017, United States; Terminated

Pfizer Investigational Site, Philadelphia, Pennsylvania 19102, United States; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213, United States; Recruiting

Pfizer Investigational Site, Abington, Pennsylvania 19001, United States; Terminated

Pfizer Investigational Site, Santiago, RM, Chile; Completed

Pfizer Investigational Site, Moscow, RUSSIA 117049, Russian Federation; Terminated

Pfizer Investigational Site, Santiago, Región Metropolitana, Chile; Completed

Pfizer Investigational Site, Providence, Rhode Island 02903, United States; Recruiting

Pfizer Investigational Site, São Paulo, SP 05651-901, Brazil; Completed

Pfizer Investigational Site, Sao Jose do Rio Preto, SP 15090-000, Brazil; Recruiting

Pfizer Investigational Site, Sioux Falls, South Dakota 57104, United States; Terminated

Pfizer Investigational Site, Sioux Falls, South Dakota 57105, United States; Terminated

Pfizer Investigational Site, Sioux Falls, South Dakota 57117-5045, United States; Terminated

Pfizer Investigational Site, Ciudad Madero, Tamaulipas 89440, Mexico; Completed

Pfizer Investigational Site, NASHVILLE, Tennessee 37232-7110, United States; Terminated

Pfizer Investigational Site, Nashville, Tennessee 37232, United States; Terminated

Pfizer Investigational Site, Nashville, Tennessee 37232, United States; Not yet recruiting

Pfizer Investigational Site, IRVING, Texas 75061, United States; Terminated

Pfizer Investigational Site, San Marcos, Texas 78666, United States; Terminated

Pfizer Investigational Site, Sequin, Texas 78155, United States; Terminated

Pfizer Investigational Site, Temple, Texas 76508, United States; Terminated

Pfizer Investigational Site, San Antonio, Texas 78229, United States; Recruiting

Pfizer Investigational Site, San Antonio, Texas 78284, United States; Recruiting

Pfizer Investigational Site, Ibague, Tolima, Colombia; Completed

Pfizer Investigational Site, Murray, Utah 84157, United States; Not yet recruiting

Pfizer Investigational Site, Richmond, Virginia 23219, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2004
Ending date: June 2010
Last updated: October 14, 2009