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

NCT00084266 | Completed Phase 4 Results

• 1 other identifier: A5951001
• Study Type: interventional
• Target: 1,225
• Locations: 22 countries
• Sites: 176

Brief Summary

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)

Keywords

Staphylococcal pneumonia; Methicillin-resistant staphylococcal pneumonia; healthcare-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  EOS (7-30 days after last dose)

Secondary Outcomes (14)

• Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population

  EOS (7-30 days after last dose)

• Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population

  EOT (within 72 hours of last dose)

• Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population

  EOT (within 72 hours of last dose)

• Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population

  EOS (7-30 days after last dose)

• Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population

  EOS (7-30 days after last dose)

Study Arms (2)

1

EXPERIMENTAL

Subjects receiving linezolid for the treatment phase of the study

Drug: linezolid (Zyvox)

2

ACTIVE COMPARATOR

Subjects receiving vancomycin for the treatment phase of the study

Drug: vancomycin

Interventions

linezolid (Zyvox) DRUG

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.

Also known as: Zyvox, linezolid

1

vancomycin DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (177)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35249, United States

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Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Montgomery, Alabama, 36106, United States

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Montgomery, Alabama, 36111, United States

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Phoenix, Arizona, 85013, United States

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Los Angeles, California, 90033, United States

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Orange, California, 92868, United States

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Redlands, California, 92373, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92120, United States

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San Diego, California, 92123, United States

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San Francisco, California, 94110, United States

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Denver, Colorado, 80204, United States

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Denver, Colorado, 80205, United States

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Denver, Colorado, 80218, United States

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Newark, Delaware, 19718, United States

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Washington D.C., District of Columbia, 20017, United States

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Washington D.C., District of Columbia, 20037, United States

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Brandon, Florida, 33511, United States

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Fort Lauderdale, Florida, 33316, United States

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Gainesville, Florida, 32610, United States

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Jacksonville, Florida, 32209, United States

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Jackson, Florida, 32209, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32801, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33607, United States

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Augusta, Georgia, 30909, United States

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Augusta, Georgia, 30912, United States

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Decatur, Georgia, 30030, United States

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Decatur, Georgia, 30033, United States

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Honolulu, Hawaii, 96817, United States

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Chicago, Illinois, 60612, United States

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North Chicago, Illinois, 60064, United States

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Oak Park, Illinois, 60302-2566, United States

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Springfield, Illinois, 62701, United States

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Springfield, Illinois, 62702, United States

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Springfield, Illinois, 62703, United States

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New Albany, Indiana, 47151, United States

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Hazard, Kentucky, 41701, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40206, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02118, United States

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Springfield, Massachusetts, 01199, United States

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Ann Arbor, Michigan, 48109-0331, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Detroit, Michigan, 48210, United States

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Saint Loius, Missouri, 63110, United States

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St Louis, Missouri, 63110-1010, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89109, United States

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Reno, Nevada, 89502, United States

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Reno, Nevada, 89503, United States

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Hackensack, New Jersey, 07601, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11215, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10011, United States

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New York, New York, 10021-9800, United States

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New York, New York, 10029, United States

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Rochester, New York, 14642-8410, United States

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Rochester, New York, 14642, United States

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The Bronx, New York, 10457, United States

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Greensboro, North Carolina, 27401, United States

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Fargo, North Dakota, 58112, United States

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Fargo, North Dakota, 58122, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45267-0558, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43214, United States

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Columbus, Ohio, 43215, United States

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Columbus, Ohio, 43222, United States

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Sylvania, Ohio, 43560, United States

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Toledo, Ohio, 43608, United States

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Toledo, Ohio, 43614, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97220, United States

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Abington, Pennsylvania, 19001, United States

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Allentown, Pennsylvania, 18103, United States

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Bethlehem, Pennsylvania, 18017, United States

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Philadelphia, Pennsylvania, 19102, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Providence, Rhode Island, 02903, United States

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Charleston, South Carolina, 29425, United States

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Sioux Falls, South Dakota, 57104, United States

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Sioux Falls, South Dakota, 57105, United States

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Sioux Falls, South Dakota, 57117-5045, United States

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Nashville, Tennessee, 37232-7110, United States

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Nashville, Tennessee, 37232, United States

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Houston, Texas, 77030-1608, United States

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Irving, Texas, 75061, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78284, United States

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San Marcos, Texas, 78666, United States

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Sequin, Texas, 78155, United States

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Temple, Texas, 76508, United States

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Murray, Utah, 84157, United States

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Richmond, Virginia, 23219, United States

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Winchester, Virginia, 22601, United States

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Buenos Aires, Buenos Aires, 1181, Argentina

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Bruges, 8000, Belgium

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Liège, B-4000, Belgium

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Salvador, Estado de Bahia, 40420-000, Brazil

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São José do Rio Preto, São Paulo, 15090-000, Brazil

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São Paulo, São Paulo, 05651-901, Brazil

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Santiago, RM, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Chile

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Barranquilla, Atlántico, Colombia

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Bogotá, Bogota. DC, Colombia

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Bogota, Cundinamarca, Colombia

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Ibagué, Tolima Department, Colombia

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Paris, Cedex 18, 75877, France

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Marseille, France, 13915, France

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Paris, 75013, France

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Saint-Etienne, 42055, France

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Göttingen, 37075, Germany

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Leipzig, 04129, Germany

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Leipzig, 04289, Germany

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Kifissia, Athens, 14561, Greece

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Crete, Greece, 71110, Greece

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Athens, 10676, Greece

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Thessaloniki, 57010, Greece

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Hong Kong, Hong Kong

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Guadalajara, Jalisco, 44280, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Monterrey/Col. Mitras Centro, Nuevo Léon, 64460, Mexico

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Ciudad Madero, Tamaulipas, 89440, Mexico

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Bytom, 41-902, Poland

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Katowice, 40-752, Poland

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Krakow, 31 - 066, Poland

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Krakow, 31-066, Poland

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Almada, 2800, Portugal

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Coimbra, 3041, Portugal

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Lisbon, 1449-005, Portugal

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Senhora da Hora, 4464-513, Portugal

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Ponce, 00716, Puerto Rico

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San Juan, 00921-3201, Puerto Rico

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Moscow, Russia, 117049, Russia

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Moscow, 111539, Russia

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Moscow, 113093, Russia

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Moscow, 115446, Russia

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Moscow, 115478, Russia

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Moscow, 123448, Russia

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Auckland Park, 2006, South Africa

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Bloefontein, 9301, South Africa

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Soweto, 2013, South Africa

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Seoul, 134-701, South Korea

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Seoul, 135-710, South Korea

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Seoul, 136-705, South Korea

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Seoul, 138-736, South Korea

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Seoul, 150-713, South Korea

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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28040, Spain

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Banqiao District, 220, Taiwan

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Kaohsiung City, 813, Taiwan

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Taichung, 404, Taiwan

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Taipei, 100, Taiwan

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Ankara, 06100, Turkey (Türkiye)

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Plymouth, Devon, PL6 8DH, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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Related Publications (4)

• 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.

  PMID: 27600290 DERIVED

• 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.

  PMID: 26196695 DERIVED

• 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.

  PMID: 24279701 DERIVED

• 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.

  PMID: 24011955 DERIVED

MeSH Terms

Conditions

Pneumonia, Staphylococcal; Healthcare-Associated Pneumonia

Interventions

Linezolid; Vancomycin

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2004
• First Posted: June 11, 2004
• Study Start: October 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 1, 2012
• Results First Posted: May 9, 2011

Record last verified: 2012-01

Locations

US (108); CO (4); GR (4); HK (1); PT (4); TU (1); BE (4); FR (4); PL (4); MY (2); DE (3); BR (3); PR (2); ZA (3); KR (5); CL (3); AR (1); ME (4); RU (6); TW (4); ES (4); GB (2)