NCT02096328

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Polyphor Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ventilator Associated Pneumonia
• Lower Respiratory Infection

Interventions

Type	Name	Description
DRUG	POL7080	Intravenous infusion

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2014-03-26
• Last updated: 2017-11-28

Locations

10 sites across 2 countries: Greece, Spain