Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
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|ClinicalTrials.gov Identifier: NCT02096328|
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : November 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ventilator Associated Pneumonia Lower Respiratory Infection||Drug: POL7080||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
Experimental: POL7080, Anti-pseudomonal antibiotics
POL7080 daily co-administered with standard of care treatment
- To measure the plasma concentrations of POL7080 [ Time Frame: Day 3 and Day 6 ]PK profile of POL7080 will be determined on Day 3 and Day 6.
- Adverse Events [ Time Frame: 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 [ Time Frame: 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.
- Clinical cure [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096328
|ATTIKON University Hospital|
|Hospital KORGIALENIO-BENAKIO E.E.S|
|SOTIRA Pulmonary Clinic|
|Hospital Del Mar|
|Hospital Clinic San Carlos|
|Hospital Joan XXIII|
|Hospital La Fe|
|Principal Investigator:||Antoni Torres, MD PhD||Hospital Clinic, Barcelona, SPAIN|
|Principal Investigator:||Evangelos Giamarellos-Bourboulis, MD PhD||ATTIKON University Hospital, Athens, GREECE|