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Not yet recruitingNCT07274020Updated Dec 10, 2025

Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients

A Phase 3 interventional study of Intermittent Moxifloxacin + Standard Care and Standard Care (in control arm) in Bronchiectasis, Non-Cystic Fibrosis, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Assiut University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiectasis, Non-Cystic Fibrosis

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03

In context

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

This study's planned enrollment of 140 is above the median of 60 across 263 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosis of cystic fibrosis-related bronchiectasis.
  • Known or to fluoroquinolones (including moxifloxacin).
  • Severe hepatic impairment or severe renal impairment ( \<30 mL/min/1.73 m²).
  • Pregnancy or breastfeeding.
  • History of significant , arrhythmia, or concurrent use of QT-prolonging drugs.
  • Use of long-term suppressive antibiotics for bronchiectasis in the past 3 months.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • 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

  • Active comparator
    Standard Care (Control)

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

    Other: Standard Care (in control arm)

Interventions

  • DrugIntermittent 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

  • OtherStandard Care (in control arm)

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

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2025
First posted
Dec 10, 2025
StartEst.
Dec 1, 2025
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Dec 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07274020
Lead sponsor
Assiut University
Responsible party
Montaser Gamal Ahmed (Lecturer of Chest Diseases and Tuberculosis, Assiut University) — Principal investigator
First posted
Dec 10, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Dec 10, 2025

Study contacts

montaser gamal ahmed, lecturer
Contact
montaser_zahran@yahoo.com
+201008951058
montaser gamal ahmed, gamal ahmed
principal investigator · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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