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Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

ConditionBronchiectasis, Non-Cystic Fibrosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Standard Care (in control arm)

    Other intervention

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Intermittent Moxifloxacin + Standard CareExperimental treatment 1 intervention
Group B: Standard Care (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exacerbation frequency

Number of acute bronchiectasis exacerbations per patient during follow-up

Time frame
12 months

Secondary outcomes

1

Microbiological clearance

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

Time frame
12 months
2

Change in FVC

Change in Forced vital capacity

Time frame
Baseline and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: