Itraconazole Therapy In Bronchiectasis With Airway Mold
Recruiting
Phase 4Interventional Study
BronchiectasisFungal Infection of Upper Respiratory Tract
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
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The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and airway mold. Feasibility will be assessed through recruitment success, treatment adherence, tolerability, and participant retention. The study will also explore the impact on respiratory symptoms and airway microbiome diversity.
Trial Locations
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Status
Eligibility Criteria
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 mo…
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
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