Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

NCT07274020 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ASSIUT-CH-MOXI-BE-25
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiectasis, Non-Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Exacerbation frequency

  Number of acute bronchiectasis exacerbations per patient during follow-up

  12 months

Secondary Outcomes (2)

• Microbiological clearance

  12 months

• Change in FVC

  Baseline and 12 months

Study Arms (2)

Intermittent Moxifloxacin + Standard Care

EXPERIMENTAL

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

Standard Care (Control)

ACTIVE COMPARATOR

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

Other: Standard Care (in control arm)

Interventions

Intermittent Moxifloxacin + Standard Care DRUG

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

Intermittent Moxifloxacin + Standard Care

Standard Care (in control arm) OTHER

Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.

Standard Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• montaser gamal ahmed, gamal ahmed

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

montaser gamal ahmed, lecturer

CONTACT

+201008951058; montaser_zahran@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Chest Diseases and Tuberculosis

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: December 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)