2024-517004-11-00招募中3 期
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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 30
- 主要终点
- Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement.
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement.
Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement.
次要结局
- -Clinical evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or clinical deterioration./-Radiological evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or deterioration
- -Major events during the 24-months follow-up period after stopping study treatment (i.e.; between visit M6 (at 6 months) and visit M30 (at 30 months).
- Relapse during the 24-months follow-up period after stopping study treatment (between visits M6 and M30).
- Mycological response after 3 and 6 months of study treatment.
- Number of medical consultations or hospitalizations for respiratory symptoms during the 6-month study treatment and the 24-month follow-up period
- Clinical and biological tolerance
- Improvement in quality of life evaluated by the VQ-11 Questionnaire
- Concordance evaluation assessment between parameters for CPA diagnosis and evolution (see ancillary project annex 3 of this protocol)
研究者
Dr Cendrine GODET
Scientific
Centre Hospitalier Universitaire De Poitiers
研究点 (30)
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