Sputum Microbiota and the Association With Clinical Parameters in Steady-state, Acute Exacerbation and Convalescence of Bronchiectasis (BISER-2)
Bronchiectasis
About this trial
This is an interventional diagnostic trial for Bronchiectasis focused on measuring Microbiota, Airway infection, Bronchiectasis, Airway inflammation, Oxidative stress, Matrix metalloproteinase
Eligibility Criteria
Inclusion Criteria:
- Patients of either sex and age between 18 and 85 years
Exclusion Criteria:
- Patient judged to have poor compliance
- Female patient who is lactating or pregnant
- Patients having concomitant severe systemic illnesses (i.e. coronary heart disease, cerebral stroke, uncontrolled hypertension, active gastric ulcer, malignant tumor, hepatic dysfunction, renal dysfunction)
- Miscellaneous conditions that would potentially influence efficacy assessment, as judged by the investigators
- Participation in another clinical trial within the preceding 3 months
Inclusion criteria for healthy subjects include all of the above criteria except for known respiratory diseases
It is estimated that 120 patients will be recruited in the study. Some of the patients in the BISER study (currently still ongoing, No.: NCT01761214) who are eligible for the current study will undergo assessments de novo, with the index date deemed as the the date of recruitment
Sites / Locations
- Guangzhou Institute of Respiratory DiseaseRecruiting
Arms of the Study
Arm 1
Other
Antibiotics
Patients will be given antibiotics based on sputum microbiology during steady-state bronchiectasis. The methodology has been described in the British Thoracic Society guideline [16]. Briefly, for first-line therapy, patients isolated with Hemophilus influenzae, Hemophilus parainfluenzae, Streptoccus pneumoniae and Moraxella catarrhalis at baseline will be treated with amoxicillin clavulanate potassium (625mg bid); patients isolated with Klebsela pneumonae or Pseudomonas aeruginosa at baseline will be treated with fluoroquinolones. Levofloxacin (500mg qd) will be empirically employed for antibiotic treatment in those who tested negative to sputum microbiology. Severe BEs could be prescribed with intravenous antibiotics therapy at the discretion of study investigators, either in the out-patient department or hospitalized for intensive systemic treatment. Hospitalized patients will not be included in the exacerbation cohort.