Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

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

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 Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis, Non-Cystic Fibrosis
• Intervention / Treatment: Drug: Intermittent Moxifloxacin + Standard Care; Other: Standard Care (in control arm)

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: montaser gamal ahmed, lecturer; Phone Number: +201008951058; Email: montaser_zahran@yahoo.com

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Assiut University Hospital
      • Contact: Montaser Gamal Elddin, Lecturer; Phone Number: +21008951058; Email: Montaser_zahran@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent Moxifloxacin + Standard Care; 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	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
Active Comparator: Standard Care (Control); Participants will receive guideline-based standard care without long-term suppressive antibiotics.	Other: Standard Care (in control arm); Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation frequency	Number of acute bronchiectasis exacerbations per patient during follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological clearance	Rate of clearance of Pseudomonas aeruginosa and other pathogens from sputum cultures	12 months
Change in FVC	Change in Forced vital capacity	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: montaser gamal ahmed, gamal ahmed, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: ASSIUT-CH-MOXI-BE-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No