To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
* Patients will be recruited after written informed consent. * Adverse events will be coded using Medical Dictionary for regulatory activities (MedDRA). * Descriptive statistics will be used for all the safety and efficacy variables.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous infusion
Hospital Bellvitge
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital La Fe
Valencia, Spain
Royal Infirmary
City of Edinburgh, United Kingdom
Sputum bacterial clearance
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
Time frame: Day 4, Day 5, Day 10, Day 15 and Day 20
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.
Time frame: Daily assessment up to 20 days from informed consent.
Laboratory abnormalities.
The number and severity of abnormal blood chemistry and hematology findings will be summarized descriptively and compared to baseline. Clinically significant values/outliers will be listed and commented.
Time frame: Day 4, Day 10, Day 15 and Day 20
Volume of sputum in 24 hours
Reduction in 24 hours sputum volume as compared to baseline will be computed
Time frame: Day 4, Day 10, Day 15 and Day 20
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