inezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus - N/A

• Conditions: MRSA infection - Nosocomial Pneumonia; MedDRA version: 7.0Level: LLTClassification code 10052596

• Registration Number: EUCTR2004-000827-13-BE
• Lead Sponsor: Pfizer Global Pharmaceutical Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-18
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Male and female subjects with a diagnosis of nosocomial pneumonia meeting all criteria listed below will be included in the study:

1. Hospitalized males and females aged 18 years of age and over
2. Subject must have clinically documented pneumonia (acquired >= 48 hours after hospitalization in an in-patient health care facility or chronic care facility or acquired from a recent hospitalization defined as subject discharged within 7 days of current admission and previously hospitalized for greater than or equal to 72 hours) with at least two of the following signs and symptoms:
- new onset or worsening of cough
- new onset of purulent sputum production or a change (worsening) in character of the sputum or increased respiratory secretions or increased suctioning requirements
- auscultatory findings on pulmonary exam of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
- dyspnea, tachypnea, or respiratory rate >= 30/minute, particularly if any or all of these are progressive in nature
- hypoxemia with a PO2 < 60 mmHg while subject is breathing room air or respiratory failure requiring mechanical ventilation in a previously non-ventilated subject
- worsening gas exchange (e.g., O2 desaturations [e.g., Pa O2/Fi O2 <= 240], increased oxygen requirements, or increased ventilation demand)

3. Subject must also have at least two of the following:
- Fever within 12 hours prior to study entry, defined as body temperature >=38ºC (100.4ºF) taken orally, >=37.5ºC (99.5ºF) axillary, >=38.5ºC (101.2ºF) tympanically, or >=39ºC (102.2ºF) rectally or hypothermia defined as body temperature <=35.5ºC (96ºF) taken orally
- systolic hypotension (systolic blood pressure < 90 mm Hg)
- temporarily altered mental status consistent with sepsis
- Elevated total peripheral white blood cell count (WBC) >=12,000/mm3 or >15% immature neutrophils (bands) regardless of total peripheral WBC or leukopenia with total WBC <4,000/mm3
4. Subject must have a positive chest X-ray (PA or AP with lateral if possible) at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia (new or progressive infiltrates or consolidation). CT scan of the thorax may be used to confirm diagnosis of pneumonia.
5. Subject must have a culture taken by an invasive technique within 24 hours of study entry or have a suitable sputum/tracheal specimen defined as having less than 10 squamous epithelial cells and greater than 25 leukocytes per low power field (10 x objective).
6. Subject must have venous access available for intravenous dosing.
7. Subject or his/her legally acceptable representative must give informed consent by signing and dating an informed consent form prior to study entry.
8. Subject must be willing to complete all study-related activities and follow-up visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

1. Subject of childbearing potential, who is unable to take adequate contraceptive precautions, has a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, or is currently breastfeeding an infant.
2. Subject with an infection due to organisms known to be resistant to either of the study drug regimens before study entry.
3. Subject with known or suspected pulmonary conditions which are likely to preclude evaluation of therapeutic response, e.g., extensive malignant disease or extensive granulomatous diseases
4. Subject with known bronchial obstruction or a history of post-obstructive pneumonia.
5. Subject with rapidly fatal underlying disease not expected to survive to complete the study.
6. Subject with high likelihood of death within 72 hours based on multiple organ dysfunction at the time of study enrollment.
7. Subject with empyema as confirmed by thoracentesis or clearly defined by CT scan. Subjects with parapneumonic effusions with no evidence of empyema may be included.
8. Subjects with lung abscess visible on plain chest x-ray or CT scan.
9. Subject who has a history of lung transplant or a recent history of bone marrow transplant (in post-transplant hospital stay). Subjects with other types of solid organ transplants may be included.
10. Subject who has cystic fibrosis or with known or suspected active tuberculosis.
11. Subject with pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, or carcinoid syndrome.
12. Subject with known or suspected meningitis, endocarditis, or osteomyelitis.
13. Subject who has clinical AIDS or a CD4 cell count < 200 cells/mm3 secondary to HIV infection.
14. Subject with sustained shock, defined as systolic blood pressure <90 mmHg or MAP < 55 mmHg for > 2 hours despite adequate fluid resuscitation and/or sympathomimetic agents to maintain blood pressure.
15. Subject with a mental condition rendering the subject unable to be cooperative with and complete study requirements.
16. Subjects who received linezolid or vancomycin for > 48 hours.
17. Subject who was 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). Certain drugs with variable MRSA activity (e.g. fluoroquinolones) may not be excluded if local susceptibility patterns will predict resistance and resistance is subsequently documented (See section 9.0 of the protocol).
18. Subject who has received any investigational drug during the previous 30 days or five times the plasma half-life (if known), whichever is longer or who have previously participated in this trial or any other protocol using linezolid in the past six months.
19. Subject with a hypersensitivity to oxazolidinones or one of the excipients in the IV formulation of linezolid (see Section 7.1.1 of the protocol)
20. Subject with a hypersensitivity to vancomycin.
21. Subject who has known liver disease and SGPT and/or SGOT > 5 X ULN (upper limit of normal).
22. Subject who has severe neutropenia (< 500 cells/mm3)
23. Subject who is a recent abuser of alcohol and/or other drugs that would result in his/her inability to participate in this trial.
24. Subject in whom concurrent use of certain medications with study drug may interfere with the evaluation of the study dr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified