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

NCT06344117 | Recruiting

• 1 other identifier: MF3 UHN (IA)
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Invasive Aspergillosis; VOC; Breath; Lung Transplant

Outcome Measures

Primary Outcomes (1)

• 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.

  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 European Organization for Research and Treatment of Cancer/Mycoses Study Group (MSG/EORTC) criteria.

  18 months

Secondary Outcomes (1)

• Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria

  18 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung transplant recipient patients undergoing bronchoscopy as a standard of care for suspected invasive fungal disease (IFD) or surveillance appointments will be eligible for screening.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Owlstone Ltd: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Respiratory droplets

Study Officials

• Shahid Husain, MD,MS

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahid Husain, MD.MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: December 12, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

CA (1)