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NCT Number: NCT07274020

Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Moxifloxacin, a fluoroquinolone antibiotic with broad-spectrum activity, may play a role in intermittent eradication therapy to reduce bacterial load, achieve microbiological clearance, and minimize exacerbation frequency.

This randomized controlled trial will evaluate the effectiveness and safety of long-term intermittent moxifloxacin therapy compared with standard care in patients with non-cystic fibrosis bronchiectasis.

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Key information

Conditions

Bronchiectasis, Non-Cystic Fibrosis Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 71515, Egypt

Location contact

Montaser Gamal Elddin, Lecturer

CONTACT

[email protected]

+21008951058

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years of age.
  • Confirmed diagnosis of non-cystic fibrosis bronchiectasis by high-resolution CT (HRCT).
  • History of ≥2 bronchiectasis exacerbations in the previous 12 months.

Exclusion criteria

  • Diagnosis of cystic fibrosis-related bronchiectasis.
  • Known hypersensitivity or contraindication to fluoroquinolones (including moxifloxacin).
  • Severe hepatic impairment or severe renal impairment (eGFR <30 mL/min/1.73 m²).
  • Pregnancy or breastfeeding.
  • History of significant QT prolongation, arrhythmia, or concurrent use of QT-prolonging drugs.
  • Use of long-term suppressive antibiotics for bronchiectasis in the past 3 months.

Treatment and study plan

Intermittent Moxifloxacin + Standard Care

Drug

Moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months), in addition to guideline-based standard care

Standard Care (in control arm)

Other

Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.

Primary outcomes

  1. Exacerbation frequency

    Time frame: 12 months

    Number of acute bronchiectasis exacerbations per patient during follow-up

Secondary outcomes

  1. Microbiological clearance

    Time frame: 12 months

    Rate of clearance of Pseudomonas aeruginosa and other pathogens from sputum cultures

  2. Change in FVC

    Time frame: Baseline and 12 months

    Change in Forced vital capacity

Study contacts

Contact information is provided by the study sponsor or research team.

montaser gamal ahmed, lecturer

CONTACT

[email protected]

+201008951058

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effectiveness and Safety of Long-Term Intermittent Moxifloxacin Eradication Therapy in Non-Cystic Fibrosis Bronchiectasis: A 12-Month Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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