Using interferon-gamma to help treat chronic pulmonary aspergillosis
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
This study is testing if adding interferon-gamma to standard antifungal treatment can help people with chronic pulmonary aspergillosis feel better, especially those who haven't improved with antifungal therapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05653193 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of interferon-gamma as an additional treatment for patients with chronic pulmonary aspergillosis (CPA), a serious lung infection caused by the Aspergillus fungus. The trial aims to determine if combining interferon-gamma with standard antifungal therapy can improve patient outcomes, particularly for those who have not responded adequately to antifungal treatment alone. Participants must have been diagnosed with CPA and started antifungal therapy within the last eight weeks. The study will assess the safety and feasibility of this combined treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with chronic pulmonary aspergillosis who have recently begun antifungal treatment.
Not a fit: Patients with severe liver dysfunction, renal failure, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and survival rates for patients suffering from chronic pulmonary aspergillosis.
How similar studies have performed: While there is limited data on the use of interferon-gamma specifically for CPA, similar immunotherapy approaches have shown promise in treating other chronic infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of CPA * Started antifungal treatment for CPA within the last 8 weeks and received no antifungals for CPA in the 8 weeks prior * Chest CT scan available within the 6 months prior to enrolment * Individuals of child bearing potential agree to have pregnancy test an use highly effective contraception Exclusion Criteria: * Moderate to severe liver dysfunction (Child-Pugh Class B or C) * Renal failure (eGFR \<30 mL/min) * Clinically diagnosed active depression * Active tuberculosis or non-tuberculous mycobacterial (NTM) lung disease * Acute infection or other event within the preceding 4 weeks which, as assessed by the investigators, might interfere with the assessment of response to treatment * Use of any interferon formulation within the preceding six months * Active viral hepatitis infection * Pregnancy or breastfeeding * Immunosuppression (\>15mg prednisolone/day for at least four weeks or equivalent) within the preceding six months * Inability to self-administer subcutaneous medications AND lack of a carer who can administer * Participants lacking capacity to consent
Where this trial is running
Manchester
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Chris Kosmidis, MD — Manchester University NHS Foundation Trust
- Study coordinator: Chris Kosmidis, MD
- Email: chris.kosmidis@manchester.ac.uk
- Phone: 01612915875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.