Itraconazole Therapy In Bronchiectasis With Airway Mold

Mayo Clinic

Status and phase

Not yet enrolling

Phase 4

Conditions

Bronchiectasis

Fungal Infection of Upper Respiratory Tract

Treatments

Drug: Itraconazole 200 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07283497

25-010613

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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