EUCTR2012-002862-11-LV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
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 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
- •medication.
- •Non-vasectomized males are required to practice effective birth control
- •(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 nature
- •? Hypoxemia defined as an arterial blood gas partial pressure of oxygen
- 另有 12 项未显示
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
- •antibacterial therapy for an indication other than the current VNP.
- •?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,
- 另有 22 项未显示
研究者
相似试验
进行中（未招募）
不适用
A Safety and Tolerability Study of Doripenem Compared with Meropenem in Children Hospitalized with Complicated Intra-abdominal InfectionsComplicated Intra-Abdominal InfectionsMedDRA version: 14.0Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2009-015864-32-Outside-EU/EEAJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium140
进行中（未招募）
1 期
未命名试验Ventilated Nosocomial PneumoniaMedDRA version: 20.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia System Organ Class: 100000004862EUCTR2012-002862-11-DECubist Pharmaceuticals LLC, an indirect wholly-owned subsidiary of Merck Sharp & Dohme Corp.726
进行中（未招募）
1 期
Assessment of the Safety Profile and Efficacy of Ceftolozane/TazobactamVentilated Nosocomial PneumoniaMedDRA version: 20.1Level: LLTClassification code 10052596Term: Nosocomial pneumoniaSystem Organ Class: 100000004862EUCTR2012-002862-11-CZCubist Pharmaceuticals LLC726
进行中（未招募）
1 期
未命名试验Ventilated Nosocomial PneumoniaMedDRA version: 20.1Level: LLTClassification code 10052596Term: Nosocomial pneumoniaSystem Organ Class: 100000004862EUCTR2012-002862-11-BECubist Pharmaceuticals LLC, an indirect wholly-owned subsidiary of Merck Sharp & Dohme Corp.726
进行中（未招募）
不适用
A Safety and Tolerability Study of Doripenem Compared with Cefepime in Hospitalized Children with Bacterial PneumoniaBacterial PneumoniaMedDRA version: 14.0Level: LLTClassification code 10004051Term: Bacterial pneumonia, unspecifiedSystem Organ Class: 10021881 - Infections and infestationsEUCTR2009-016069-27-Outside-EU/EEAJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium140