Using breath analysis to diagnose invasive aspergillosis in lung transplant recipients

Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients A Prospective Pilot Study

This study is testing whether analyzing breath samples can help doctors find invasive aspergillosis in lung transplant patients more easily.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Owlstone Ltd (Industry-sponsored)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06344117 on ClinicalTrials.gov

What this trial studies

This observational pilot study aims to evaluate the effectiveness of analyzing volatile organic compounds (VOCs) in exhaled breath to detect invasive aspergillosis in lung transplant recipients suspected of having invasive fungal disease. The study addresses the challenges of diagnosing invasive aspergillosis, which is often difficult due to the limitations of current diagnostic methods. By utilizing non-invasive breath sampling techniques, researchers hope to identify specific metabolic signatures that could indicate the presence of the disease. The findings could lead to improved early detection and treatment strategies for affected patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have received a single or double lung transplant and are suspected of having invasive fungal disease.

Not a fit: Patients on mechanical ventilation or with confirmed bacterial or viral respiratory infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance early diagnosis and treatment of invasive aspergillosis, potentially improving patient outcomes.

How similar studies have performed: Previous studies have shown promise in using breath analysis for diagnosing various respiratory diseases, but this specific application for invasive aspergillosis is novel.

Eligibility criteria

Inclusion Criteria: Patients with the following criteria will be included in the study:

1. Over the age of 18 years
2. Recipient of single/double lung transplant
3. Willingness to participate in the study
4. Suspected of invasive fungal disease or undergo surveillance appointments
5. Capable of providing sample
6. Capable of providing consent

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Exclusion Criteria: Patients with the following criteria will be excluded from the study:

1. On mechanical ventilation, oxygen supplementation including nasal cannula; simple, fixed, or non-rebreathing face mask at presentation.
2. Admitted to the intensive care unit at presentation.
3. The subject is currently diagnosed with a confirmed bacterial or viral respiratory infection or has received a diagnosis of a respiratory viral or bacterial infection within the last 4 weeks.
4. Previous diagnosis of Cystic Fibrosis
5. Use of antifungals in previous 4 weeks
6. Has been previously diagnosed with respiratory fungal infection other than aspergillus within the last 3 months upon presentation.
7. Declines participation in the study.
8. On mold antifungal for \>72 hours.

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Where this trial is running

Toronto, Ontario

• University Health Network — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Shahid Husain, MD,MS — University Health Network, Toronto
• Study coordinator: Shahid Husain, MD.MS

Conditions Invasive Aspergillosis; VOC; Breath; Lung Transplant