Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

Assiut University

Status and phase: Not yet enrolling; Phase 3

Conditions: Bronchiectasis, Non-Cystic Fibrosis

Treatments: Other: Standard Care (in control arm); Drug: Intermittent Moxifloxacin + Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07274020

ASSIUT-CH-MOXI-BE-25

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Intermittent Moxifloxacin + Standard Care

Experimental group

Description:

Participants will receive 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

Treatment:

Drug: Intermittent Moxifloxacin + Standard Care

Standard Care (Control)

Active Comparator group

Description:

Participants will receive guideline-based standard care without long-term suppressive antibiotics.

Treatment:

Other: Standard Care (in control arm)