Recruiting

Itraconazole

Sponsor:

Mayo Clinic

Code:

NCT07283497

Conditions

Bronchiectasis

Fungal Infection of Upper Respiratory Tract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Itraconazole 200 mg

Study Details

Brief summary:

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.

Conditions

Bronchiectasis

Fungal Infection of Upper Respiratory Tract

Study ID

NCT07283497

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bronchiectasis

Subjects with bronchiectasis and airway mold

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Pulmonary Clinical Research Office

800-753-1606McNamara.Jennifer2@mayo.edu

Jennifer McNamara, BS

507-266-6705McNamara.Jennifer2@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Pulmonary Clinical Research Office

800-753-1606

Principal Investigator:

Amjad Kanj, MD, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.