Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia

Inclusion criteria

• Male and female patients ≥18 years of age diagnosed with VAP , i.e., pneumonia that arises more than 96 hours after endotracheal intubation documented or suspected to be due to Pseudomonas aeruginosa
• Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
• Written Informed consent from the patient's legally acceptable representative or a relative

Exclusion criteria

• Patients with known hypersensitivity to fluoroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a clinically significant history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening
• Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
• Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25
• Presence of septic shock at the time of evaluation for study entry
• History of lung transplant
• Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
• Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
• Patients with impaired renal function
• Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent