Study period | |||||||
---|---|---|---|---|---|---|---|
Enrollment | Intervention | Follow-up | |||||
Visit number | 1 | 2 | 3 | 4 | 5 | 6 | |
Study day | 0 | 0–14 | 14 | 30 | 60 | 90 | 365 |
Enrollment | |||||||
Eligibility screening | X | ||||||
Informed consent | X | ||||||
Randomization | X | ||||||
Study arm | |||||||
Intervention group: antibiotic treatment, in-hospital | X | ||||||
Control group: no antibiotic treatment, not hospitalized | |||||||
Data collection and examinations | |||||||
Demographics | X | ||||||
Sputum sample | X | X | X | X | X | X | |
Body mass index (BMI) | X | X | X | X | X | X | |
Medical Research Council Dyspnea Scale (MRC) | X | X | X | X | X | X | |
COPD Assessment Test (CAT) | X | X | X | X | X | X | |
Spirometry | X | X | X | X | X | X | |
Vital parameters | X | X | |||||
High-resolution computed tomography (HRCT) | X | ||||||
Blood samples | X | X | X |