Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.
- Conditions
- Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-002202-31-GB
- Lead Sponsor
- Polyphor Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
1.Male* and female** aged ?18 to <80 and suffering from documented non-cystic fibrosis bronchiectasis***.
* Men should practice contraception up to 75 days after the end of treatment.
**Women of child bearing potential should practice a reliable method of contraception up to 30 days after the end of treatment.
***The diagnosis of bronchiectasis must have been made by high-resolution computed tomography or by bronchogram and documented in the patient?s record.
2.Patients currently having an exacerbation with:
Increased cough.
Increased volume of sputum production.
Increase in sputum purulence.
3.Patients with documented Pseudomonas aeruginosa infection for the current episode or a positive rapid test for Pseudomonas aeruginosa in the sputum at inclusion or known to be chronically infected with Pseudomonas aeruginosa in the past or isolation of Pseudomonas aeruginosa in the sputum culture at least 2 times in the last 12 months prior to inclusion (from patient records).
4.Sputum sample collected for quantitative culture before starting treatment.
5.Venous access available for IV dosing.
6.Written informed consent from patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br><br>a.Safety and tolerability.<br>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 Outcome Measures
Name Time Method