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

Canada45 participantsStarted 2023-12-12

Plain-language summary

Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. On mechanical ventilation, oxygen supplementation including nasal cannula; simple, fixed, or non-rebreathing face mask at presentation.
✕. Admitted to the intensive care unit at presentation.
✕. 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.
✕. Previous diagnosis of Cystic Fibrosis
✕. Use of antifungals in previous 4 weeks
✕. Has been previously diagnosed with respiratory fungal infection other than aspergillus within the last 3 months upon presentation.
✕. Declines participation in the study.
✕. On mold antifungal for \>72 hours.

What they're measuring

Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria.

Timeframe: 18 months

Trial details

NCT IDNCT06344117

SponsorOwlstone Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07

Contact for this trial

Shahid Husain, MD.MS

(416) 340-3144 shahid.husain@uhn.ca

View on ClinicalTrials.gov More Invasive Aspergillosis trials