EUCTR2012-002862-11-CZ进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Multicenter, Phase 3Study to Assess the Safety and Efficacy of IntravenousCeftolozane/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
- 性别
- All
入选标准
- •To be eligible for enrollment, a subject must satisfy all of the following entry criteria:
- •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 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 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/FiO2 ratio)
- •Receiving mechanical ventilation =48 hours and at least one of the following:
- •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
- •Hypoxemia defined as an arterial blood gas partial pressure of oxygen less than 60 mmHg while the subject is breathing room air (or FiO2 equivalent), OR a pulse oximetry oxygen saturation less than 90% while the subject is breathing room air (or FiO2 equivalent), OR worsening PaO2/FiO2.
- •4. Chest radiograph obtained within the 24 hours prior to the first dose of study drug shows the presence of new or pr
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
- •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 (ie, 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
- •3. Received systemic or inhaled antibiotic therapy effective against
- •Gram-negative
- •pathogens that cause VNP, for >24 hours in the 72 hours prior to the
- •first dose of study drug.
- •Drugs with only Gram-positive activity [eg, daptomycin, vancomycin,
- •linezolid] are
- •Exceptions:
- •?Persistent/worsening signs and/or symptoms of VNP are still present
- •=48 hours of antibiotic therapy for the treatment of the current VNP, and
- •LRT culture obtained while the subject is on the failing antibiotic therapy
- •for this episode of VNP showed growth of a Gram-negative pathogen and
- •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. NOTE: Subjects on =48 hours of antibiotics for infection prophylaxis (rather than treatment of a documented or suspected infection) are not eligible for enrollment under this exception
- •?Treatment with a non-absorbed antibiotic used for gut
- •decontamination (eg,
- •low-dose erythromycin) or to eradicate C. difficile.
- •4. Baseline Gram stain shows the presence of only Gram-positive
- •Exception: If the subject has a lower respiratory tract culture growing a
- •Gramnegative
- •pathogen obtained within 72 hours prior to the first dose of study drug,
- •results will supersede baseline Gram stain results of only Gram-positive
- •5. Active immunosuppression, including human immunodeficiency virus
- •(HIV) with a
- •known CD4 count of <200 cells/mm3, active hematological malignancy,
- •recipients of
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