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:
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:
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.