Comparing Itraconazole with Standard Care for Chronic Aspergillus Infection in Bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of oral itraconazole combined with standard care compared to standard care alone in reducing exacerbations in patients with non-cystic fibrosis bronchiectasis who have chronic Aspergillus infection. The study will include adult participants who have been clinically stable for at least three months and have specific IgG levels indicating chronic infection. By investigating the role of itraconazole, the trial seeks to address the gap in understanding the impact of fungal infections on bronchiectasis exacerbations. The methodology involves monitoring exacerbation rates and lung function over the course of the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria: adults subjects (≥13 years) with non-cystic fibrosis bronchiectasis fulfilling all the following criteria: • bronchiectasis on thin-section computed tomography (CT)

* chronic aspergillus infection defined by the presence of A.fumigatus-specific IgG ≥40 mgA/L
* clinically stable for at least three months prior to study inclusion

Exclusion Criteria:

We will exclude subjects with any of the following:

* allergic bronchopulmonary aspergillosis as the cause of underlying bronchiectasis
* cystic fibrosis
* post-tuberculosis bronchiectasis
* severe asthma
* current smokers
* active bacterial, mycobacterial (atypical or typical), or fungal (aspergillosis or mucormycosis) infections
* use of systemic antifungal drugs in past 3 months
* previous documented intolerance to itraconazole
* pregnancy
* failure to provide informed consent

Where it's running

• Chest clinic
  Chandigarh, Chandigarh, India Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.