EUCTR2004-000827-13-GB进行中（未招募）1 期
INEZOLID IN THE TREATMENT OF SUBJECTS WITH NOSOCOMIAL PNEUMONIA PROVEN TO BE DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS - N/A
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •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 <60 mm Hg while subject is breathing room air or respiratory failure requiring mechanical ventilation in a previously non-ventilated subject
- •worsening gas exchange
- •3 Subject must present with criteria described in 3a or 3b prior to enrolment. Signs/symptoms must have been present within 24hrs 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 either 24hrs prior to that treatment or 72hrs prior to enrolment.
- •a. At least two of the following:
- •Fever defined as body temperature =38°C orally; =38.4°C rectally, tympanically, via temporal artery or core; = 37.5°C axillary or hypothermia defined as body temperature =35.5°C orally or =35.9°C rectally, tympanically, via temporal artery or core
- •Systolic hypotension (systolic blood pressure <90 mm Hg)
- •Temporarily altered mental status consistent with sepsis
- •Elevated total peripheral white blood cell count (WBC) >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.
- •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
排除标准
- •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 < 200 cells/mm3 secondary to HIV infection unless the subject has been on treatment with highly active anti-retroviral therapy (HAART) is on PCP prophylaxis, and clinically and immunologically stable (with CD4 counts from 100-199 and granulocytes= 1000). The subject may be enrolled at the discretion of the investigator after investigator discussion with the medical monitor.
- •Subject with sustained shock, defined as MAP < 55 mmHg (or if MAP not available, systolic BP < 85 mm Hg) for > 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 including segmented cells and bands) unless neutropenia is reversible and count is expected to be >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.
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