Itraconazole Therapy In Bronchiectasis With Airway Mold
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Itraconazole 200 mg.
- Who it may be relevant to
- Registry conditions: Bronchiectasis, Fungal Infection of Upper Respiratory Tract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Itraconazole Therapy In Bronchiectasis With Airway Mold: A Single-Arm Pilot Trial Of Feasibility, Safety, And Impact On Respiratory Symptoms And Airway Microbiome Diversity
Overview
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.
Interventions
- Drug Itraconazole 200 mg
Subjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.
Primary outcome measures
- Proportion of eligible patients who consent and enroll [Time frame: 2 years]
- Number of patients to achieve successful medication adherence [Time frame: 2 years]
- Proportion of participants who complete treatment without adverse effects [Time frame: 2 years]
- Proportion of patients retained for complete study [Time frame: 2 years]
Secondary outcome measures (2)
- Number of participants meeting hepatic safety discontinuation criteria [Time frame: Baseline, 1 week]
- Number of participants with a QTc interval greater than 500 ms [Time frame: Baseline, 1 week]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07283497 · 25-010613