NCT04966793 Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasis Patients.
| NCT ID | NCT04966793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Bronchiectasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,850 participants |
| Start Date | 2020-02-20 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,850 participants in total. It began in 2020-02-20 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Qualified sputum samples from bronchiectasis patients were collected regularly every month for three consecutive years to analyze the microbiome changes of lower respiratory tract of bronchiectasis patients by metagenomic sequencing. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution，including virulence, quorum sensing and drug resistance under host pressure. The aim of the study is to clarify the rule of microflora colonization distribution and adaptive evolution in the lower respiratory tract of patients with bronchiectasis, to predict the acute attack and prognosis of patients with microbiome changes, and to find more new prevention and treatment methods by adjusting the microbiome of the lower respiratory tract.
Eligibility Criteria
Inclusion Criteria: * Bronchiectasis patients in clinically stable period; * Two or more chest infections in the previous year; * Chest CT confirmed bronchiectasis (bronchial to arterial ratio \>1). * Chronic colonization of pseudomonas aeruginosa and was clinically stable in 6 months prior to the study. Exclusion Criteria: * deterioration of illness (defined as at least 24 hours of three or more of the following symptoms: increased cough, increased sputum volume, purulent sputum, hemoptysis, increased dyspnea, increased wheezing, fever ((≥38°C) or discomfort, the attending physician agrees that antibiotic treatment is required); * current smokers, or former smokers who have stopped smoking less than 1 year ago, have a history of more than 15 packets of age, or CT showed as emphysema; * cystic fibrosis patients; * active allergic bronchopulmonary aspergillosis; * active tuberculosis patients; * patients with poor asthma control; * pregnant or breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04966793 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04966793 currently recruiting?
Yes, NCT04966793 is actively recruiting participants. Contact the research team at xufeng99@zju.edu.cn for enrollment information.
Where is the NCT04966793 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04966793 clinical trial?
NCT04966793 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 1,850 participants.