Recruiting

Volatile Organic Compounds

Sponsor:

Owlstone Ltd

Code:

NCT06344117

Conditions

Invasive Aspergillosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Invasive Aspergillosis

Study ID

NCT06344117

Start date

Dec 12, 2023

Status verified date

Mar, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Controls

patients without evidence of Aspergillus colonization or Aspergillus related disease

Colonised Aspergillus

patients with Aspergillus colonization

Invasive Aspergillus

patients with proven or probably IA

Primary outcome measure

  • 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. [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Principal Investigator:

Shahid Husain, MD,MS

More Information

Sponsor

Owlstone Ltd

Last update posted

Apr 3, 2024

Last verified

Mar, 2024

Keywords

  • Invasive Aspergillosis
  • VOC
  • Breath
  • Lung Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Owlstone Ltd on 2024-04-03.