Bronchoscopic Amikacin for Acute Exacerbations in Bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares three approaches in adults with acute bronchiectasis exacerbations: standard care, bronchoscopy with saline lavage, and bronchoscopy with saline lavage plus local amikacin. Participants are allocated equally to the three groups and followed during the acute episode to observe outcomes. The procedure involves bronchoalveolar lavage to clear secretions, with the addition of a targeted antibiotic dose in the experimental arm. The goal is to see if local amikacin delivery improves recovery or delays recurrence compared with standard treatment and lavage alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged between 18 and 80 years, inclusive.
2. According to the adult bronchiectasis guidelines, diagnosed with bronchiectasis, and indicating lesions accumulating in 2 or more lung lobes.
3. Presenting with an acute exacerbation, defined by worsening of key symptoms (e.g., cough, sputum volume, dyspnea, chest tightness, or wheezing), and willing to undergo bronchoscopy with bronchoalveolar lavage (BAL).
4. Patients who are alert, cooperative, and able to tolerate the bronchoscopic procedure.
5. Provided written informed consent to participate in this clinical trial.

Exclusion Criteria:

1. Presence of severe comorbidities or any contraindications to flexible bronchoscopy.
2. Intraoperative oxygen desaturation (SpO₂) or inability to tolerate bronchoalveolar lavage (BAL) following bronchoscopic insertion.
3. Declined participation or was deemed ineligible by the investigator for other reasons.
4. Coagulopathy (platelet count \< 50 × 10⁹/L) or active airway bleeding observed during bronchoscopy, posing a potential risk of exacerbation from BAL.
5. Incomplete procedural documentation or missing follow-up data.
6. Known allergy or hypersensitivity to amikacin.
7. Concurrent renal failure.
8. Diagnosis of cystic fibrosis.

Where it's running

• The First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Zhongbo Chen
• Email: leonczb@163.com
• Phone: +8613777125910

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.