Actively Recruiting
Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
Led by Poitiers University Hospital · Updated on 2025-02-20
224
Participants Needed
1
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study compares the therapeutic (clinical and radiological) efficacy of a six-month treatment by itraconazole and nebulised Ambisome® (liposomal amphotericin B = LAmB) versus treatment by itraconazole alone, in non - or mildly - immunocompromised patients affected by Chronic Pulmonary Aspergillosis (single aspergilloma excluded). • Control arm: Itraconazole 200 mg x 2/day associated with inactive nebulised treatment twice a week during 24 weeks. • Experimental arm: Itraconazole 200 mg x 2/day associated with nebulised LAmB, at 25 mg twice a week during 24 weeks. Follow up duration for the patients will be 24 months (12 months minimum) after discontinuation of the treatment being studied.
CONDITIONS
Official Title
Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with Chronic Pulmonary Aspergillosis (new or relapsed without itraconazole resistance)
- Diagnosis confirmed by compatible thoracic CT scan showing cavitary, fibrotic, necrotizing, or nodular Aspergillus infection
- Positive anti-Aspergillus IgG or antibodies, or positive Aspergillus culture or histological evidence
- Women of childbearing age must have a negative pregnancy test and use highly effective contraception for at least 12 months
- Legal capacity to consent and no guardianship or protective measures
- Affiliated to France's Health Care Regime (S�ecurit� Sociale)
- Signed free and informed consent
You will not qualify if you...
- Presence of single aspergilloma
- Contraindications to itraconazole or related contraindicated medications
- Contraindications to voriconazole or posaconazole
- Intolerance to beta2-agonists
- History of itraconazole-resistant Aspergillus relapse
- Hypersensitivity to liposomal amphotericin B, itraconazole, or study ingredients
- Previous complications from nebulised liposomal amphotericin B
- Recent antifungal treatment within last 2 months (except oral Amphotericin B)
- Severe renal failure (clearance <30 ml/min)
- Severe liver failure with high enzyme levels
- Significant abnormal blood cell or platelet counts
- Use of treatments contraindicated with study drugs
- Cardiac dysfunction or arrhythmia with prolonged QT interval
- Invasive pulmonary Aspergillosis or Allergic Bronchopulmonary Aspergillosis
- CPA requiring surgery within 6 months
- Cystic Fibrosis
- Immunocompromised status
- Active severe hemoptysis
- Active tuberculosis or progressive non-tuberculous mycobacterial infection
- Respiratory infection worsening CPA
- Refusal to participate
- Legal or social protections limiting consent
- Recent participation in antifungal interventional studies
- Women not using effective contraception, pregnant, or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
C
Céline DELETAGE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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