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Not yet recruiting NCT07274020

Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

Phase III Interventional Bronchiectasis, Non-Cystic Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intermittent Moxifloxacin + Standard Care, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: Bronchiectasis, Non-Cystic Fibrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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
  • Other Standard Care (in control arm)
    Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.

Primary outcome measures

  • Exacerbation frequency [Time frame: 12 months]
Secondary outcome measures (2)
  • Microbiological clearance [Time frame: 12 months]
  • Change in FVC [Time frame: Baseline and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut University hospital — Asyut

Identifiers

NCT: NCT07274020 · ASSIUT-CH-MOXI-BE-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗