[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100336104":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":68,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":27,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":27,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":27,"overallStatus":54,"whyStopped":27,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Poitiers University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Itraconazole & inhaled placebo","PLACEBO_COMPARATOR","Itraconazole 200 mg x 2\u002Fday associated with inactive nebulised treatment (isotonic saline) twice a week during 24 weeks.",[13,14],"Drug: inhaled placebo","Drug: Itraconazole",{"label":16,"type":17,"description":18,"interventionNames":19},"Itraconazole & inhaled Ambisome®","EXPERIMENTAL","Itraconazole 200 mg x 2\u002Fday associated with inhaled liposomal amphotericin B (Ambisome®) at 25 mg twice a week during 24 weeks",[20,14],"Drug: inhaled Ambisome®",[22,28,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","inhaled Ambisome®","inhaled liposomal amphotericin B = inhaled LAmB",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"inhaled placebo","inhaled isotonic saline",[9],[33],"placebo (for Ambisome®)",{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Itraconazole","Itraconazole tablet",[16,9],[39],"Sporanox®",[41],{"name":42,"affiliation":43,"role":44},"Cendrine GODET, MD","Bichat Hospital, AP-HP","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Céline DELETAGE","CONTACT","+33 5 49 44 38 54","celine.deletage@chu-poitiers.fr",[52],{"facility":53,"status":54,"city":55,"state":27,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"CHU Poitiers","RECRUITING","Poitiers","86000","France","FR",{"type":60,"coordinates":61},"Point",[62,63],0.34348,46.58261,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":67,"phoneExt":27,"email":50},"+33549443854",{"type":69,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100336104","phase-3-chronic-pulmonary-aspergillosis-and-ambisome-aerosol-with-itraconazole-100336104",false,"NCT03656081","Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole","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)","Inclusion Criteria:\n\nAll 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:\n\n1. Patient with an Aspergillus bronchopulmonary infection, be it cavitary, fibrotic, necrotizing (SIA\u002FSemi Invasive Aspergillosis) or nodular and documented by compatible thoracic CT-scan images ;\n2. Associated with one of the following criteria:\n\n   * positive detection of anti-Aspergillus IgG and\u002For precipitating anti-aspergillus antibodies, according to the positivity threshold of the laboratory performing the technique,\n   * positive direct examination of Aspergillus or positive culture, from bronchopulmonary samples (expectoration or endoscopic aspiration),\n   * revealing aspergillar hyphae\u002Ffilaments on histological samples\n3. Men or women age ≥ 18 years;\n4. 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;\n5. Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures;\n6. Participants must be affiliated to France's Health Care Regime (\" Sécurité Sociale \");\n7. Free and informed consent signed by each participating patient.\n\nExclusion Criteria:\n\n1. \\- Patient affected with single aspergilloma\n2. \\- 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)\n3. \\- Patient presenting a contraindication to voriconazole and posaconazole (including all contraindicated coadministrated medications as listed in the SmPc)\n4. \\- Intolerance to beta2-agonists\n5. \\- Notion of relapse with isolation of an Aspergillus resistant to itraconazole\n6. \\- History of hypersensitivity reaction to liposomal amphotericin B or to itraconazole or to any other constituent\n7. \\- Patient having presented complications related to a previous treatment by nebulised LAmB\n8. \\- Patient received an oral (excepted oral Amphotericin B), parenteral or intra-cavity antifungal treatment within the last 2 months\n9. \\- Severe renal failure (clearance \\\u003C30 ml \u002F min).\n10. \\- Hepatic failure with transaminase and alkaline phosphatase values \\> 5 times normal\n11. \\- Significant abnormality of the blood cell and platelet counts (at the discretion of the investigator)\n12. \\- Concomitant use of one or several of treatments contra-indicated with the experimental or non-experimental treatment\n13. \\- 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.\n14. \\- Invasive pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis\n15. \\- Chronic Pulmonary Aspergillosis with indication for surgical intervention within 6 months from the start\n16. \\- Patients with Cystic Fibrosis\n17. \\- Immunocompromised patients\n18. \\- Threatening hemoptysis, with impossibility to defer surgical procedures (but patients contraindicated to surgery may be included after resolution of the hemoptysis)\n19. \\- Tuberculosis or progressive non-tuberculous mycobacteria\n20. \\- Respiratory infection aggravating the underlying CPA (patient may be included after eradication of infection)\n21. \\- Patient refusing to participate\n22. \\- 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.\n23. \\- Patient in exclusion period following participation in another interventional study evaluating antifungals or medicines\n24. \\- Women at age to procreate and not using highly effective contraception, pregnant or breastfeeding women","ALL","18 Years",{"count":80,"type":81},224,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","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).\n\n• Control arm: Itraconazole 200 mg x 2\u002Fday associated with inactive nebulised treatment twice a week during 24 weeks.\n\n• Experimental arm: Itraconazole 200 mg x 2\u002Fday associated with nebulised LAmB, at 25 mg twice a week during 24 weeks.\n\nFollow up duration for the patients will be 24 months (12 months minimum) after discontinuation of the treatment being studied.",[87],"Chronic Pulmonary Aspergillosis","2025-02-18",{"date":90,"type":91},"2025-02-20","ACTUAL",{"date":93,"type":91},"2018-12-19",{"date":95,"type":81},"2029-12",{"name":5,"class":6},1]