Pneumonia Clinical Trial
Official title:
A Non-comparative Open Pilot Trial to Assess the Safety and Pharmacokinetics of up to Three Single Doses of AERUMAB 11 (KBPA-101) in Patients With Hospital Acquired Pneumonia Caused by Serotype O11 P. Aeruginosa
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of KBPA-101 every third day in addition of standard of care antibiotic treatment.
Hospital acquired pneumonia (HAP) is a pneumonia occurring 48 hours or more after hospital admission. HAP occurs in patients on conventional hospital wards and in intensive care units (ICU), some of them associated to mechanical ventilation, known as Ventilator Associated Pneumonia (VAP). VAP is the most common infection on intensive care units representing 82% of HAP cases. Pseudomonas aeruginosa is one of the most frequent pathogens involved in ICU-HAP and despite of adequate treatment its crude mortality remains as high as 70% of the cases. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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