Bronchiectasis, Lower Respiratory Infection
Conditions
Keywords
POL7080, Pseudomonas aeruginosa, Non cystic fibrosis bronchiectasis, Exacerbation
Brief summary
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
Detailed description
* 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.
Interventions
DRUGPOL7080
Intravenous infusion
Sponsors
Polyphor Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female aged ≥18 to \<80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection 2. Sputum sample collected for culture before starting treatment
Exclusion criteria
1. Female patients who are pregnant or breast feeding or unwilling to follow reliable method of 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. Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count \< 200/mm3 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sputum bacterial clearance | Day 4, Day 5, Day 10, Day 15 and Day 20 | Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Daily assessment up to 20 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. | Day 4, Day 10, Day 15 and Day 20 | 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. |
| Volume of sputum in 24 hours | Day 4, Day 10, Day 15 and Day 20 | Reduction in 24 hours sputum volume as compared to baseline will be computed |
Other
| Measure | Time frame | Description |
|---|---|---|
| To measure the plasma concentrations of POL7080 | Day 3 | Blood samples to measure POL7080 concentrations before, during and after administration of POL7080 |
Countries
Spain, United Kingdom
Outcome results
None listed