EUCTR2012-002862-11-AT进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/tazobactam Compared With Meropenem in Adult Patients with Ventilated Nosocomial Pneumonia (VNP) - Assessment of the Safety Profile and Efficacy of Ceftolozane/Tazobactam in Nosocomial Pneumonia
Cubist Pharmaceuticals LLC, an indirect wholly-owned subsidiary of Merck Sharp & Dohme Corp.0 个研究点目标入组 726 人开始时间: 2015年1月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 726
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
- 性别
- All
入选标准
- •1. Provide written informed consent prior to any study-related procedure not part of normal medical care. If the subject is unable to do so, local country laws and institution specific guidelines and requirements in place for obtaining informed consent should be met. A legally acceptable representative may provide consent, provided this is approved by local country and institution specific guidelines. If a subject comes to consciousness while still in the study and per the Investigator's
- •judgment the subject is able to read, assess, understand, and make
- •his/her own decision to participate in the trial, the subject can agree to
- •continue study participation and the subject may be re-consented, if
- •required by local country and institution specific guidelines.
- •2. Be males or females aged 18 years or older. If female, subject must
- •not be pregnant or nursing, and is either:
- •Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral
- •oophorectomy, or hysterectomy; or
- •Of childbearing potential and meets at least 1 of the following:
- •- Is practicing an effective method of contraception (eg, oral/parenteral
- •contraceptives plus barrier method), or
- •- Has a vasectomized partner, or
- •- Is currently abstinent from sexual intercourse.
- •Subjects must be willing to practice the chosen contraceptive method or remain abstinent during the conduct of the study and for at least 35 days after last dose of study medication.
- •Non-vasectomized males are required to practice effective birth control
- •methods (eg, abstinence, use of condom, or use of other barrier device)
- •during the treatment period and for at least 35 days after last dose of
- •study medication.
- •3. Intubated (via endotracheal tube, including tracheostomy patients)
- •and on mechanical ventilation at the time of randomization:
- •For ventilated HABP:
- •At least 1 of the following signs and/or symptoms must be present
- •within the 24 hours prior to intubation OR within the 48 hours after intubation in a patient who has been either hospitalized for =48 hours or who has been discharged from a hospital within the prior 7 days (includes patients institutionalized in skilled nursing or other long-term care facility):
- •- A new onset of cough (or worsening of baseline cough)
- •- Dyspnea, tachypnea, or respiratory rate greater than 30 per minute,
- •particularly if any or all of these signs or symptoms are progressive in
- •- Hypoxemia defined as an arterial blood gas partial pressure of oxygen
- •less than 60 mmHg while the subject is breathing room air, OR a pulse
- •oximetry oxygen saturation less than 90% while the subject is breathing
- •room air, OR worsening of the ratio of the partial pressure of oxygen to
- •the fraction of inspired oxygen (PaO2/FiO2ratio).
- •For VABP, receiving mechanical ventilation =48 hours:
- •Acute changes made in the ventilator support system to enhance
- •oxygenation, as determined by worsening partial pressure of oxygen on
- •arterial blood gas, or worsening PaO2/FiO2.
- •4. Chest radiograph shows the presence of new or progressive
- •infiltrate(s) suggestive of bacterial pneumonia (based on Investigator
- •evaluation or report from a qualified medical professional who is not the Investigator). A computed tomography (CT) scan may be used in place of a chest X-ray.
- •5. Have the following clinical criteria within the 24 hours prior to the
- •first dose of study drug:
排除标准
- •1. Any of the following diagnoses or conditions that interfere with the
- •assessment or interpretation of outcome:
- •Atypical, viral, or fungal (including Pneumocystis jiroveci), known or
- •suspected community-acquired bacterial pneumonia
- •Tracheobronchitis (without documented pneumonia), chemical
- •pneumonitis, or postobstructive pneumonia
- •Active primary or metastatic lung cancer
- •Pleural effusions (or empyema) requiring therapeutic drainage, lung abscess, or bronchiectasis
- •Cystic fibrosis, acute exacerbation of chronic bronchitis, or active
- •pulmonary tuberculosis
- •New York Heart Association (NYHA) Stage IV Congestive Heart Failure
- •or Cirrhotic Liver Disease
- •Full thickness burns (greater than 15% of total body surface area)
- •Severe confounding respiratory condition due to penetrating chest
- •trauma (i.e., chest trauma with paradoxical respiration).
- •2. Has a documented history of any moderate or severe hypersensitivity
- •(or allergic) reaction to any ß-lactam antibacterial;
- •Note: A history of a rash while on a ß-lactam antibiotic does not
- •automatically exclude a subject (eg, a subject with history of a mild rash
- •followed by uneventful re exposure may be considered for enrollment).
- •3. Received systemic or inhaled antibiotic therapy for treatment of the current VNP, effective against Gram-negative pathogens that cause VNP, for >24 hours (i.e., >1 dose of a once daily antibiotic, >2 doses of a
- •twice daily antibiotic, etc.) in the
- •72 hours prior to the first dose of study drug. Drugs with only Grampositive activity [eg, daptomycin, vancomycin, linezolid] are allowed.
- •Exceptions:
- •Persistent/worsening signs and/or symptoms of VNP are still present despite =48 hours of antibiotic therapy for the treatment of the current VNP, and (a) a LRT culture obtained while the subject is on the failing antibiotic therapy for this episode of VNP showed growth of a Gramnegative pathogen and (b) the isolated pathogen is not known to be resistant to one of the study drugs
- •Signs and/or symptoms of VNP develop after receiving =48 hours of prior antibacterial therapy for an indication other than the current VNP
- •Treatment with a non-absorbed antibiotic therapy used for gut
- •decontamination (eg, low-dose erythromycin) or to eradicate C.
- •4. Baseline Gram stain shows the presence of only Gram-positive
- •Exception: If the subject has a lower respiratory tract culture growing a Gram-negative pathogen obtained within 72 hours prior to the first dose of study drug, these results will supersede baseline Gram stain results of only Gram-positive bacteria.
- •5. Active immunosuppression, including human immunodeficiency virus (HIV) with a known CD4 count of <200 cells/mm3, active hematological malignancy, recipients of solid organ or bone marrow transplants, subjects currently on immunosuppressive therapy including cancer chemotherapy, medications for prevention of transplant rejection, or chronic administration of corticosteroids (defined as >40 mg of prednisone per day administered continuously for more than 14 days prior to the first dose of study drug).
- •6. Receipt of >24 hours of a carbapenem within 7 days prior to the first dose of study drug
- •7. Growth of a meropenem-resistant or ceftolozane/tazobactamresistant, Gram-negative pathogen from a respiratory or blood culture, within 15 days prior to the first dose of study drug.
- •8. Development of end-stage renal disease defined as a CLCR <15
- •mL/min, OR requirement fo
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