Clinical Research Details

Descriptive Information
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

Souha Kanj Shararah


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

  • Cubist Pharmaceuticals, LLC (formerly known as Cubist Pharmaceuticals, Inc.), an indirect wholly-owned subsidiary of Merck & Co., Inc
Conditions and Keywords
Ventilator associated Bacterial Pneumonia, Hospital Acquired Bacterial Pneumonia,Ventilated Nosocomial Pneumonia
Ceftolozane/Tazobactam,Meropenem,Ventilated Nosocomial Pneumonia
Study Design
Safety and/or Efficacy Study
Double Blind
Eligibility and IRB
Min: 18

Nosocomial Pneumonia (NP) is a type of lung infection that can develop in patients admitted to a hospital for 2 days or more. NP may be caused by being on a ventilator (also known as ventilator – associated bacterial pneumonia or VABP) or may result in you being put on a ventilator (also known as ventilated hospital acquired bacterial pneumonia or HABP). It is associated with increased morbidity, mortality, and prolongation of hospital stay. The therapeutic effectiveness of current therapies for nosocomial pneumonia is limited by the increasing prevalence of pathogens that are multi-drug resistant, emphasizing the need for development of new and effective antimicrobials.

The purpose of this clinical research study is to learn whether the investigational drug Ceftolozane/Tazobactam can safely and effectively treat patients with NP, compared to Meropenem, an approved and commercially available antibiotic commonly used to treat these conditions. 

Intubated (via endotracheal tube, including tracheostomy patients) and on mechanical ventilation at the time of randomization

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.

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

3- Intubated (via endotracheal tube, including tracheostomy patients) and on mechanical ventilation at the time of randomization

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 (ie, chest trauma with paradoxical respiration)

2. Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial;

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.