MRSA Infection - Nosocomical Pneumenia MedDRA version: 8.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia
Conditions
Interventions
Trade Name: Zyvox®/Zyvoxid®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Linezolid
CAS Number: 165800-03-3
Current Sp
Sponsors
Pfizer Pharmaceutical Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Hospitalized males and females =aged 18 years of age 2 Subject must have clinically documented • Nosocomial pneumonia defined as pneumonia with clinical picture onset =48hrs after hospitalization in an acute in-patient healthcare facility. Subject may also be enroled upon transfer from another acute care facility if the clinical picture onset of pneumonia was after hospitalization at that facility for =48hrs OR Healthcare-associated pneumonia defined as pneumonia acquired in a long-term care or sub-acute/intermediate healthcare facility or in subject admitted with pneumonia following recent hospitalization or pneumonia in subject who has received chronic dialysis care within 30d prior to study enrolment WITH at least 2 of the following signs/symptoms present within 24 hrs of study enrolment in subjects who have not been treated pre-study with an antimicrobial active against subject’s MRSA isolate. In subjects who have been treated, symptoms and findings must be present within 24hrs prior to that treatment or within 72 hrs prior to enrolment: new onset or worsening of cough new onset of purulent sputum production or change in character of sputum or increased respiratory secretions or increased suctioning requirements auscultatory findings on pulmonary exam of rales and/or pulmonary consolidation dyspnea, tachypnea, or respiratory rate =30/min, particularly if any or all of these are progressive in nature hypoxemia with PO2 10,000/mm3 or >15% immature neutrophils regardless of total peripheral WBC or leukopenia with total WBC <4,500/mm3 Positive quantitative culture for MRSA from a baseline respiratory specimen obtained by an invasive procedure. Subject may be enrolled without either preliminary or final results of culture. In addition, subject may be enrolled based on planned procedure or prior to report of quantitative culture results. OR b. New onset of purulent sputum production or change in character of sputum or increased respiratory secretions or increased suctioning requirements AND at least one of the following: Fever defined as body temperature =38°C orally; =38.4°C rectally, tympanically, via te
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: Subject with rapidly fatal underlying disease not expected to survive to complete the study. Subject with high likelihood of death within 72 hours based on multiple organ dysfunction at the time of study enrollment. Subject with known or suspected meningitis, endocarditis, or osteomyelitis. Subject who has a CD4 cell count 2 hours despite adequate fluid resuscitation and/or sympathomimetic agents to maintain blood pressure. Subject who was treated with linezolid, vancomycin or teicoplanin for greater than 48 hours within the 72 hour period prior to the enrollment. Also excluded are subjects treated for greater than 48 hours with one of the above drugs, and drug began prior to the 72 hour preenrollment period but drug treatment continued into the 72 hour pre-study period. Subject who was treated for the infection under study prior to this timeframe may be enrolled unless the subject received 72 hours or more of treatment and did not respond. Subject who was treated with a previous antibiotic with MRSA activity against the subject’s isolate (other than linezolid, vancomycin or teicoplanin) for greater than 48 hours within the 72 hour period prior to the enrollment. Also excluded are subjects treated for greater than 48 hours and drug began prior to the 72 hour pre- enrollment period but drug treatment continued into the 72 hour pre-study period. Subjects who received = 72 hours of an antibiotic with activity against the subject’s MRSA isolate (other than linezolid, vancomycin or teicoplanin) for the infection under study and were documented to be a treatment failure may be enrolled. Certain drugs with variable MRSA activity (e.g. fluoroquinolones) may not be excluded if local susceptibility patterns will predict non-susceptibility and is subsequently documented. Subject who has severe liver disease (Child-Pugh Class C hepatic insufficiency), or subject with SGPT and/or SGOT > 5 X ULN (upper limit of normal). Subject who has severe neutropenia (neutrophils 500 cells/ mm3 within 24 hours following first dose of study drug. Subject who is currently on peritoneal dialysis or alternative treatment for renal failure (e.g., hemofiltration, CVVH). Subjects on hemodialysis may be enrolled. Subject in whom his/her weight would require a vancomycin dosing frequency with intervals less than 12 hours if they were randomized to vancomycin, thereby not allowing the blind to be maintained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults.;Secondary Objective: To compare the bacteriological efficacy and the safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults.;Primary end point(s): Clinical response will be determined by the investigator and evaluated at EOT and EOS for subjects with a baseline MRSA pathogen. Clinical response will be based primarily on the global assessment of the clinical presentation of the subject made by the investigator at the evaluation timepoint. Bacteriological response will be determined by the Sponsor and evaluated at the EOT and at the EOS visits for subjects with a baseline MRSA pathogen. | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed