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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Ventilator Associated Pneumonia, Lower Respiratory Infection

Intervention / Treatment
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* Drug: POL7080


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POL7080, Anti-pseudomonal antibiotics<br>POL7080 daily co-administered with standard of care treatment | Drug: POL7080<br>* Intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the plasma concentrations of POL7080 | PK profile of POL7080 will be determined on Day 3 and Day 6. | Day 3 and Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Death, discontinuations and serious adverse events will be listed and narrative summaries will be provided. | Daily assessment up to 34 days from informed consent. | 
| Laboratory abnormalities | The number and severity of blood chemistry and hematology abnormal findings will be summarized descriptively and compared to baseline. Clinically significant values/outliers will be listed and commented. | Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator Associated Pneumonia (VAP), Lower respiratory infection, POL7080, Pseudomonas aeruginosa, Nosocomial pneumonia