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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Itraconazole 200 mg
DrugSubjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: BronchiectasisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of eligible patients who consent and enroll
Recruitment will be measured as the proportion of eligible patients who consent and enroll out of patients screened, reported as a percentage, with a benchmark of \>60%.
Time frame
2 years2
Number of patients to achieve successful medication adherence
Adherence will be assessed through pill counts with successful adherence defined as ≥ 70% of doses taken and achieving a therapeutic trough level.
Time frame
2 years3
Proportion of participants who complete treatment without adverse effects
Tolerability will be evaluated as the proportion of participants who complete the 6-week course without discontinuation due to adverse effects, with a target benchmark of ≥ 70%.
Time frame
2 years4
Proportion of patients retained for complete study
Retention will be defined as the proportion of participants completing all scheduled study visits (baseline, day 7 and end of treatment), with a goal of ≥ 80% retention.
Time frame
2 yearsSecondary outcomes
1
Number of participants meeting hepatic safety discontinuation criteria
Hepatic safety will be monitored with serial hepatic function panels obtained at baseline, day 7, with the endpoint defined as the number of participants meeting discontinuation criteria: total bilirubin more than 2 times the ULN according to Mayo laboratory reference, ALT more than two times the ULN, AST more than two times the ULN, or ALP greater than 250 U/L.
Time frame
Baseline, 1 week2
Number of participants with a QTc interval greater than 500 ms
Cardiac safety will be assessed by obtaining an ECG on day 7, with the endpoint defined as the proportion of participants with a QTc interval greater than 500 ms.
Time frame
Baseline, 1 weekSponsors and contacts
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Source ClinicalTrials.gov