Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.
Conditions
Sponsors
Polyphor Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male* and female** aged ?18 to =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception (in women of child bearing age). Men who are unwilling to follow contraception. 2. Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis. 3. Current exacerbation of bronchiectasis is associated with lung abscess or empyema. 4. Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa. 5. Change or addition to maintenance anti-pseudomonas antibiotics including inhalation antibiotics within 4 weeks prior to current exacerbation. 6. Change or increase in total daily dose of maintenance macrolide antibiotics within 8 weeks prior to current exacerbation. 7. Change or increase in total daily dose of systemic or local corticosteroids or NSAIDs within 8 weeks prior to current exacerbation. 8. Patients with known HIV infection with CD4+ cell count < 200/mm3. 9. Patients with life threatening arrhythmia identified at study baseline or having been diagnosed and/or treated for life threatening arrhythmia in the last 6 months. 10. Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 6 weeks of study entry. 11. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent. 12. Creatinine clearance <60mL/min. If the patient develops renal insufficiency (with creatinine clearance of <50mL/minute in 2 consecutive measurements within 24 hours) after the inclusion, the POL7080 treatment should be discontinued and the patient treated with different anti pseudomonas antibiotic(s) as per the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of POL7080 administered for 10 to 14 days in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Secondary Objective: ?To investigate POL7080 for the following parameters: a.Safety and tolerability. b.Pharmacokinetics/pharmacodynamics of POL7080.;Primary end point(s): Sputum Bacterial clearance [reduction in the daily quantitative viable counts of (cfu/mL) Pseudomonas aeruginosa by at least 1-log].;Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated througout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and tolerability of POL7080 by evaluating adverse events (AEs), changes in vital signs, physical examination results, blood chemistry, haematology and ECG parameters. 2. Pharmacokinetics/pharmacodynamics of POL7080, by assessing the correlation of selected PK parameters of POL7080 with primary end points and selected secondary end points. 3. Time to log reductions in cfu/mL of Pseudomonas aeruginosa as compared to baseline. 4. 24-h sputum volume. 5. Sputum purulence score. 6. Total WBC count, serum C-reactive protein (CRP) and procalcitonin (PCT). 7. Lung function tests: FEV1 (% predicted), FVC (% predicted), FEV1/FVC ratio. 8. Microbiology: a) The in vitro susceptibility [(MIC - minimum inhibitory concentration performed at the central laboratory) of POL7080 and selected anti pseudomonas antimicrobials for the baseline Pseudomonas aeruginosa isolates will be summarised and compared. b) All Pseudomonas aeruginosa isolates that show any increase in MIC to POL7080, as compared to baseline, during the daily sputum culture will be summarized. The sero typing results of such isolates will also be presented. c) Microbiological response at TOC. 9. Patient Reported Outcome (PRO): Leicester Cough Questionnaire (LCQ), St. George`s Respiratory Questionnaire (SGRQ). 10. Evaluation of following biomarkers: Sputum Myeloperxidase (SMPO), Sputum Elastase Activity (SEA), sputum cell counts, IL6 and IL8 (wherever possible).;Timepoint(s) of evaluation of this end point: Secondary endpoint will be evaluated througout the study | — |
Countries
Germany, Spain, United Kingdom
Contacts
Public ContactNúria Bordas
Trial Form Support
Outcome results
None listed