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

A Phase II, Open-label, Multi-center Study to Assess Pharmacokinetics (PK), Safety and Efficacy of POL7080 Co-administered With Standard of Care (SoC) Treatment in Patients With Ventilator- Associated Pneumonia (VAP) Due to Suspected or Documented Pseudomonas Aeruginosa Infection.

To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection

Inclusion Criteria:

1. 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
2. Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
3. Written Informed consent from the patient's legally acceptable representative or a relative

Exclusion Criteria:

1. 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
2. Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
3. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25
4. Presence of septic shock at the time of evaluation for study entry
5. History of lung transplant
6. Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
7. Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
8. Patients with impaired renal function
9. 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