Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

NCT ID: NCT07274020

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Intermittent Moxifloxacin + Standard Care

Intervention Type: 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

Standard Care (Control)

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

Group Type: ACTIVE_COMPARATOR

Standard Care (in control arm)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

Standard Care (in control arm)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Montaser Gamal Ahmed

Lecturer of Chest Diseases and Tuberculosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

montaser gamal ahmed, gamal ahmed

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

montaser gamal ahmed, lecturer

Role: CONTACT

montaser_zahran@yahoo.com

+201008951058

Facility Contacts

Montaser Gamal Elddin, Lecturer

Role: primary

Montaser_zahran@yahoo.com

+21008951058

Other Identifiers

ASSIUT-CH-MOXI-BE-25

Identifier Type: -

Identifier Source: org_study_id