Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Poitiers University Hospital (Voir sur ClinicalTrials)
décembre 2018
décembre 2029
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | PHILIPPE | 04/07/2024 11:04:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Poitiers - 86000 - Poitiers - France | Céline DELETAGE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
All adult patients affected with Chronic Pulmonary Aspergillosis (CPA) "de novo" or in
relapse (without any history of resistance to itraconazole) combining the following
criteria are eligible:
1. 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 ;
2. Associated with one of the following criteria:
- positive detection of anti-Aspergillus IgG and/or precipitating
anti-aspergillus antibodies, according to the positivity threshold of the
laboratory performing the technique,
- positive direct examination of Aspergillus or positive culture, from
bronchopulmonary samples (expectoration or endoscopic aspiration),
- revealing aspergillar hyphae/filaments on histological samples
3. Men or women age ≥ 18 years;
4. 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;
5. Patient legally free and not subject to any custody, guardianship, tutelage or
subordination measures;
6. Participants must be affiliated to France's Health Care Regime (" Sécurité Sociale
");
7. Free and informed consent signed by each participating patient.
All adult patients affected with Chronic Pulmonary Aspergillosis (CPA) "de novo" or in
relapse (without any history of resistance to itraconazole) combining the following
criteria are eligible:
1. 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 ;
2. Associated with one of the following criteria:
- positive detection of anti-Aspergillus IgG and/or precipitating
anti-aspergillus antibodies, according to the positivity threshold of the
laboratory performing the technique,
- positive direct examination of Aspergillus or positive culture, from
bronchopulmonary samples (expectoration or endoscopic aspiration),
- revealing aspergillar hyphae/filaments on histological samples
3. Men or women age ≥ 18 years;
4. 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;
5. Patient legally free and not subject to any custody, guardianship, tutelage or
subordination measures;
6. Participants must be affiliated to France's Health Care Regime (" Sécurité Sociale
");
7. Free and informed consent signed by each participating patient.
1.
- Patient affected with single aspergilloma
2.
- 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)
3.
- Patient presenting a contraindication to voriconazole or posaconazole
(including all contraindicated coadministrated medications as listed in the
SmPc)
4.
- Intolerance to beta2-agonists
5.
- Notion of relapse with isolation of an Aspergillus resistant to itraconazole
6.
- History of hypersensitivity reaction to liposomal amphotericin B or to
itraconazole or to any other constituent
7.
- Patient having presented complications related to a previous treatment by
nebulised LAmB
8.
- Patient received an oral (excepted oral Amphotericin B), parenteral or
intra-cavity antifungal treatment within the last 2 months
9.
- Severe renal failure (clearance <30 ml / min).
10.
- Hepatic failure with transaminase and alkaline phosphatase values > 5 times
normal
11.
- Significant abnormality of the blood cell and platelet counts (at the
discretion of the investigator)
12.
- Concomitant use of one or several of treatments contra-indicated with the
experimental or non-experimental treatment
13.
- 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 corrected QT
interval > 450 msec in men and 470 msec in women or treated by medication known
to prolong QT interval, or prolongation of the corrected QT interval > 450 msec
in men and 470 msec in women.
14.
- Invasive pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
15.
- Chronic Pulmonary Aspergillosis with indication for surgical intervention
within 6 months from the start
16.
- Patients with Cystic Fibrosis
17.
- Immunocompromised patients
18.
- Threatening hemoptysis, with impossibility to defer surgical procedures (but
patients contraindicated to surgery may be included after resolution of the
hemoptysis)
19.
- Tuberculosis or progressive non-tuberculous mycobacteria
20.
- Respiratory infection aggravating the underlying CPA (patient may be included
after eradication of infection)
21.
- Patient refusing to participate
22.
- 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.
23.
- Patient in exclusion period following participation in another interventional
study evaluating antifungals or medicines
24.
- Women at age to procreate and not using highly effective contraception,
pregnant or breastfeeding women