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CPAAARI-Therapeutic efficacy comparison of a six-month treatment by itraconazole and nebulised Ambisome® versus treatment by itraconazole alone in non- or mildly- immunocompromised patients with Chronic Pulmonary Aspergillosis: a prospective, randomized, single blind study, (single aspergilloma excluded).
EU CTIS ID: 2024-517004-11-00
What this study is testing
Compare the therapeutic (clinical and radiological) efficacy of a six-month treatment by itraconazole and nebulised Ambisome® versus treatment by itraconazole alone, in non - or mildly - immunocompromised patients affected by Chronic Pulmonary Aspergillosis (single aspergilloma excluded).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient with an Aspergillus bronchopulmonary infection, be it cavitary, fibrotic, necrotizing (SIA/Semi Invasive Aspergillosis) or nodular and documented by compatible thoracic CT-scan images
- Associated with one of the following criteria: 1-positive detection of anti-Aspergillus IgG and/or precipitating anti-Aspergillus antibodies, according to the positivity threshold of the laboratory performing the technique/2-positive direct examination of Aspergillus or positive culture, from bronchopulmonary samples (expectoration or endoscopic aspiration)/3-revealing aspergillar hyphae/filaments on histological samples
- Men or women age ≥ 18 years
- For the women of childbearing age: women having a negative serum pregnancy test, having a contraception highly effective and accepting to pursue it during at least the first 12 months of the study
- Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
- Participants must be affiliated to France's Health Care Regime (« Sécurité Sociale »);
You likely can't join if
- Patient affected with single aspergilloma
- Hepatic failure with transaminase and alkaline phosphatase values > 5 times normal
- Significant abnormality of the blood cell and platelet counts (at the discretion of the investigator)
- Concomitant use of one or several of treatments contra-indicated with the experimental or non-experimental treatment
- Ventricular dysfunction such as congestive cardiac failure or history of congestive cardiac failure or patients with risk(s) factors of cardiac arrhythmia or symptomatic arrhythmia with a prolongation of the QTc interval > 450 msec in men and 470 msec in women or treated by medication known to prolong QT interval, or prolongation of the QTc interval > 450 msec in men and 470 msec in women
- Invasive pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
See the full eligibility criteria
Who can join
- Patient with an Aspergillus bronchopulmonary infection, be it cavitary, fibrotic, necrotizing (SIA/Semi Invasive Aspergillosis) or nodular and documented by compatible thoracic CT-scan images
- Associated with one of the following criteria: 1-positive detection of anti-Aspergillus IgG and/or precipitating anti-Aspergillus antibodies, according to the positivity threshold of the laboratory performing the technique/2-positive direct examination of Aspergillus or positive culture, from bronchopulmonary samples (expectoration or endoscopic aspiration)/3-revealing aspergillar hyphae/filaments on histological samples
- Men or women age ≥ 18 years
- For the women of childbearing age: women having a negative serum pregnancy test, having a contraception highly effective and accepting to pursue it during at least the first 12 months of the study
- Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
- Participants must be affiliated to France's Health Care Regime (« Sécurité Sociale »);
- Free and informed consent signed by each participating patient.
What rules you out
- Patient affected with single aspergilloma
- Hepatic failure with transaminase and alkaline phosphatase values > 5 times normal
- Significant abnormality of the blood cell and platelet counts (at the discretion of the investigator)
- Concomitant use of one or several of treatments contra-indicated with the experimental or non-experimental treatment
- Ventricular dysfunction such as congestive cardiac failure or history of congestive cardiac failure or patients with risk(s) factors of cardiac arrhythmia or symptomatic arrhythmia with a prolongation of the QTc interval > 450 msec in men and 470 msec in women or treated by medication known to prolong QT interval, or prolongation of the QTc interval > 450 msec in men and 470 msec in women
- Invasive pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
- Chronic Pulmonary Aspergillosis with indication for surgical intervention within 6 months from the start
- Patients with Cystic Fibrosis
- Immunocompromised patients (HIV Seropositivity (except if the disease is controlled and with no contraindications between azole and antiretroviral treatments), AIDS, progressive neoplastic disease, systemic disease in active phase, immunosuppressor treatment, allograft or autograft of bone marrow, haematologic disease (acute or chronic leukaemia, multiple myeloma, Hodgkin's disease …), organ transplants, neutropenia (ANC < 500 / mm3) during the 3 months preceding the inclusion, systemic corticotherapy > 7,5 mg / day prednisolone (or equivalent) > 3 weeks
- Threatening hemoptysis, with impossibility to defer surgical procedures (but patients contraindicated to surgery may be included after resolution of the hemoptysis)
- Tuberculosis or progressive non-tuberculous mycobacteria
- Patient presenting a contraindication to itraconazole (including all contraindicated co-administrated medications as listed in the itraconazole SmPc, including notably medications with potential to prolong theQT interval)
- Respiratory infection aggravating the underlying CPA (patient may be included after eradication of infection)
- Patient refusing to participate
- Protected majors in the meaning of the law, non affiliated persons or with no social security scheme, persons deprived of liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies.
- Patient in exclusion period following participation in another interventional study evaluating antifungals or medicines
- Women at age to procreate and not using highly effective contraception (either hormonal / mechanical [oral, injection, subcutaneous, implantable, intrauterine device] or surgical [tubal ligation, hysterectomy, total ovariectomy]: at least as concerns the initial 12 months of the study, pregnant or breastfeeding women
- Patient presenting a contraindication to voriconazole and posaconazole (including all contraindicated coadministrated medications as listed in the SmPc).
- Intolerance to beta2-agonists
- Notion of relapse with isolation of an Aspergillus resistant to itraconazole
- History of hypersensitivity reaction to liposomal amphotericin B or to itraconazole or to any other constituent
- Patient having presented complications related to a previous treatment by nebulised LAmB
- Patient received an oral (excepted oral Amphotéricine B), parenteral or intra-cavity antifungal treatment within the last 2 months
- Severe renal failure (clearance <30 ml / min
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.