Itraconazole Therapy In Bronchiectasis With Airway Mold
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Itraconazole 200 mg
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov