Itraconazole for bronchiectasis with airway mold

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4, single-center interventional feasibility study gives adults with bronchiectasis and recent airway mold growth oral itraconazole 200 mg to test practical use in this population. Feasibility outcomes include recruitment success, medication adherence, tolerability, and participant retention. Exploratory outcomes include changes in respiratory symptoms and diversity of the airway microbiome measured from sputum. Participants are enrolled through the Mycobacterial and Bronchiectasis Clinic at Mayo Clinic in Rochester, Minnesota with eligibility confirmed by chest CT and recent sputum cultures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years seen at Mycobacterial and Bronchiectasis Clinic (MMBC) in Rochester
* Diagnosis of bronchiectasis confirmed by MMBC provider and chest CT
* Within the last 3 months - culture growth of a mold in high quantity ('many') or culture growth of at least two distinct mold species in any quantity
* Not actively on antimicrobial therapy AND no current plan to initiate antimicrobial therapy at the time of enrollment, as determined by treating provider
* Ability to produce spontaneous sputum at Visit 1.

Exclusion Criteria:

* Known diagnosis of allergic bronchopulmonary aspergillosis or invasive fungal disease
* Use of the following medications: rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, dofetilide, quinidine, dronedarone, simvastatin, lovastatin, certain immunosuppressants (tacrolimus, cyclosporine, sirolimus, everolimus) and anticoagulants (rivaroxaban, apixaban, edoxaban, warfarin).
* Abnormal baseline liver function tests (ALT, AST, alkaline phosphatase, or bilirubin \> upper limit of normal)
* Prolonged QTc interval on baseline ECG (\>460 ms in females or \>450 ms in males)
* History of congestive heart failure (black box warning), known cardiomyopathy, or arrhythmias
* Pregnancy or lactation
* Known hypersensitivity or contraindication to azole antifungal therapy
* Prior use of systemic antifungals within the past 3 months

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Amjad Kanj, MD — Mayo Clinic
• Study coordinator: Pulmonary Clinical Research Office
• Email: McNamara.Jennifer2@mayo.edu
• Phone: 800-753-1606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.