Bronchiectasis
Conditions
Brief summary
PA-eradication rate 6 months after the start of antibiotic therapy targeting PA
Detailed description
Exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation, Exacerbation assessment at each follow-up visit, Quality-of-life and treatment burden assessment using questionnaires, Quality of Life-Bronchiectasis (QOL-B), Bronchiectasis Impact Measure (BIM), Treatment Burden Questionnaire (TBQ) (+ EQ-5D-5L questionnaire for the medico-economic analysis), Detection of PA at 3-month and 1 year, PA-recurrence in sputum (or lower respiratory tract sample, if clinically justified), with time (in days) between the start of antibiotic therapy against PA and first PA-recurrence, Analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months, AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study, Compliance to treatment and AEs will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days), Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days), Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days), Total cost in each group, total quality adjusted life years (QALYs) in each group, difference in costs /difference in QALYs
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PA-eradication rate 6 months after the start of antibiotic therapy targeting PA | — |
Secondary
| Measure | Time frame |
|---|---|
| Exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation, Exacerbation assessment at each follow-up visit, Quality-of-life and treatment burden assessment using questionnaires, Quality of Life-Bronchiectasis (QOL-B), Bronchiectasis Impact Measure (BIM), Treatment Burden Questionnaire (TBQ) (+ EQ-5D-5L questionnaire for the medico-economic analysis), Detection of PA at 3-month and 1 year, PA-recurrence in sputum (or lower respiratory tract sample, if clinically justified), with time (in days) between the start of antibiotic therapy against PA and first PA-recurrence, Analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months, AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study, Compliance to treatment and AEs will be recorded during medical interviews | — |
Countries
France