Itraconazole Therapy In Bronchiectasis With Airway Mold

Overview

About this study

The primary objective of this study is to assess feasibility of itraconazole in patients with bronchiectasis and mold in the airway. This will include recruitment, adherence, tolerability, and retention.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥18 years seen at MMBC clinic 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 antimicrobia therapy at the time of enrollment, as determined by the 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

  • Prior use of systemic antifungals within the past 3 months.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/10/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amjad Kanj

Open for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606

PCRUE18@mayo.edu

More information

Publications

Publications are currently not available