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Starting soon Phase 3

Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

NCT07274020 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2025-12-01
Last updated
2025-12-10

Condition(s) studied

Bronchiectasis, Non-Cystic Fibrosis

Investigational drug(s) / intervention(s)

Intermittent Moxifloxacin + Standard CareStandard Care (in control arm)

Intermittent Moxifloxacin + Standard Care: 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): Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Exacerbation frequency — 12 months
    Number of acute bronchiectasis exacerbations per patient during follow-up

Trial sites (1)

FacilityCityRegionStatus
Assiut University hospital Asyut Asyut Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07274020 on ClinicalTrials.gov ↗ ← All trials in Egypt