Lower Respiratory Infection, Ventilator Associated Pneumonia
Conditions
Keywords
Ventilator Associated Pneumonia (VAP), Lower respiratory infection, POL7080, Pseudomonas aeruginosa, Nosocomial pneumonia
Brief summary
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
Interventions
DRUGPOL7080
Intravenous infusion
Sponsors
Polyphor Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the plasma concentrations of POL7080 | Day 3 and Day 6 | PK profile of POL7080 will be determined on Day 3 and Day 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Daily assessment up to 34 days from informed consent. | 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. |
| Laboratory abnormalities | Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure | Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 | Clinical cure will be measured based on clinical signs and symptoms and radiological findings. |
| Reduction in bacterial count | Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 | Reduction in CFU/mL (colony forming unit /mL) of Pseudomonas aeruginosa in the daily quantitative cultures. |
Countries
Greece, Spain
Outcome results
None listed