Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

Phase 3Not Yet RecruitingNCT07274020

Assiut University140 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Bronchiectasis, Non-Cystic Fibrosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Exacerbation frequency

Number of acute bronchiectasis exacerbations per patient during follow-up

Time frame: 12 months

Secondary Outcomes

Microbiological clearance

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

Time frame: 12 months

Change in FVC

Change in Forced vital capacity

Time frame: Baseline and 12 months