EUCTR2012-002862-11-GR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 - Assessment of the Safety Profile and Efficacy of Ceftolozane/Tazobactam
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •To be eligible for enrollment, a subject must satisfy all of the following entry criteria before they will be allowed to participate in the study and prior to any study related procedures:
- •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 or symptoms within 24 hours prior to intubation OR within the 48 hours after intubation of a patient hospitalized for >48 hours or have 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 nature
- •?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 PaO
排除标准
- •A subject will not be enrolled if the subject meets any of the following criteria:
- •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 (ie, >1 dose of a once daily antibiotic, >2 doses of a twice daily antibiotic, etc.) in the last 72 hours.
- •Exceptions:
- •Signs and/or symptoms of VNP are still present despite >48 hours on the prior antibacterial regimen for this episode of VNP, provided the prior respiratory or blood culture did not grow a meropenem-resistant Gram-negative pathogen, or only S. aureus (methicillin-susceptible S. aureus [MSSA] or methicillin-resistant S. aureus [MRSA]). Requires microbiological confirmation of a Gram-negative pathogen.
- •Develops signs and/or symptoms of VNP while receiving >48 hours of prior antibacterial therapy for indication other than the current VNP.
- •Prior therapy with a non-absorbed antibiotic therapy used for gut decontamination (example, low-dose erythromycin) or to eradicate C. difficile.
- •4.Gram stain performed within 36 hours prior to first dose shows presence of only Gram-positive bacteria.
- •Note: ETA specimens with an average of >10 SECs and <25 polymorphonuclear cells per low power field will be considered inadequate, and a repeat specimen will need to be obtained for Gram stain and subsequent quantitative culture.
- •5.Active immunosuppression, including Acquired Immune Deficiency Syndrome (AIDS), 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 randomization);
- •Note: Subjects infected with the human immunodeficiency virus (HIV) but who do no
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