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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POL7080, Anti-pseudomonal antibiotics | Experimental | POL7080 daily co-administered with standard of care treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL7080 | Drug | Intravenous infusion |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | Clinical cure will be measured based on clinical signs and symptoms and radiological findings. | Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 |
| Reduction in bacterial count | Reduction in CFU/mL (colony forming unit /mL) of Pseudomonas aeruginosa in the daily quantitative cultures. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Torres, MD PhD | Hospital Clinic, Barcelona, SPAIN | Principal Investigator |
| Evangelos Giamarellos-Bourboulis, MD PhD | ATTIKON University Hospital, Athens, GREECE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATTIKON University Hospital | Athens | Greece | ||||
| Hospital EVANGELISMOS |
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| 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 |
| Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 |
| Athens |
| Greece |
| Hospital KORGIALENIO-BENAKIO E.E.S | Athens | Greece |
| SOTIRA Pulmonary Clinic | Athens | Greece |
| Hospital Bellvitge | Barcelona | Spain |
| Hospital Clinic | Barcelona | Spain |
| Hospital Del Mar | Barcelona | Spain |
| Hospital Clinic San Carlos | Madrid | Spain |
| Hospital Joan XXIII | Tarragona | Spain |
| Hospital La Fe | Valencia | Spain |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D011552 | Pseudomonas Infections |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000629572 | murepavadin |
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