[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584715":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":44,"locations":52,"responsibleParty":80,"collaborators":82,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":30,"enrollmentInfo":150,"targetDuration":30,"studyType":153,"phases":154,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":171,"whyStopped":30,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 2 - randomized study (group 1)","EXPERIMENTAL","Conventional systemic antifungal treatment (systemic co-trimoxazole or systemic second line anti-Pneumocystis salvage therapy) + aerosols of echinocandin (50 mg caspofungin) during one to seven days (according to the regimen retained from the results of part 1 from day-1 to d-7) using vibrating mesh nebulization device",[13],"Drug: Caspofungin Acetate 50 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Part 2 - randomized study (group 2)","PLACEBO_COMPARATOR","Control group: (in part 2 only) Conventional systemic antifungal treatment (systemic co-trimoxazole or systemic second-line anti-Pneumocystis salvage therapy) + aerosols of placebo (0.9% saline in a volume equivalent to the experimental group) during one to seven days (according to the regimen retained from part 1 results) using vibrating mesh nebulization device",[19],"Drug: Physiologic saline",{"label":21,"type":10,"description":22,"interventionNames":23},"Part 1 - open study","open-label non-randomized group, with ascending scheme regarding the dose and rhythm of administration over one week, depending on the tolerance, and closely monitored in ICU to ensure that caspofungin is well tolerated via the inhaled route, and to provide data supporting the proposed administration scheme for part 2.\n\n* the first two patients (included one by one) will receive two aerosols (5 mg) during the first week, four days apart on d-1 and d-5 (level 1);\n* the third and fourth will receive two aerosols (15 mg) during the first week, four days apart on d-1 and d-5 (level 2);\n* the fifth and sixth will receive two aerosols (50 mg) during the first week, four days apart on d-1 and d-5 (level 3);\n* the seventh and eighth patients will receive four aerosols (50 mg) two days apart during one week, at d-1, then d-3, d-5 and d-7 (level 4);\n* the last two patients will have daily aerosols during the first week, from d-1 to d-7 (level 5)",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Caspofungin Acetate 50 MG","The experimental treatment will be administered once daily for up to seven days, through the nebulization route by the means of a disposable vibrating mesh Aeroneb solo® nebulizer with the valved mask (Galway, Ireland). Before generating aerosol, resuspension of the caspofungin powder will be carried out in the same manner than for the IV route, into 10.5 mL saline serum. Preparation of the experimental drug (re-suspension) will be unblindly carried out in a distinct medical office by a nurse neither involved in the healthcare of the included patients, nor in the other parts of the study, data recording or outcome assessment. Once reconstituted, the suspension is expected to be limpid, with neither odour nor foam. Thereafter, its administration will be blindly completed by the clinical staff in charge of the enrolled patient.",[21,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Physiologic saline","Procedures will be exactly the same than those described above for the experimental group, but caspofungin will be replaced during the seven days of intervention by 10mL of 0.9% saline nebulized in the control group for a 15 minute-long process of nebulization (from d-1 to d-7).",[15],[36,40,42],{"name":37,"affiliation":38,"role":39},"Guillaume DESOUBEAUX, Prof","University Hospital of TOURS","STUDY_DIRECTOR",{"name":41,"affiliation":38,"role":39},"Stephan EHRMANN, Prof",{"name":43,"affiliation":38,"role":39},"Adrien LEMAIGNEN, Dr",[45,49],{"name":37,"role":46,"phone":47,"phoneExt":30,"email":48},"CONTACT","+33(0)2 34 37 89 26","guillaume.desoubeaux@univ-tours.fr",{"name":41,"role":46,"phone":50,"phoneExt":30,"email":51},"+33(0)6 71 10 33 02","stephanehrmann@gmail.com",[53],{"facility":54,"status":30,"city":55,"state":30,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"CHU Tours","Tours","37000","France","FR",{"type":60,"coordinates":61},"Point",[62,63],0.70398,47.39484,{"lat":63,"lon":62},[66,70,73,75,78],{"name":67,"role":46,"phone":68,"phoneExt":30,"email":69},"Elodie MOUSSET, MSc","+33 2 47 47 46 65","E.MOUSSET@chu-tours.fr",{"name":71,"role":46,"phone":72,"phoneExt":30,"email":48},"Guillaume DESOUBEAUX, MD PhD","+33 2 34 37 89 26",{"name":71,"role":74,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"name":76,"role":77,"phone":30,"phoneExt":30,"email":30},"Stephan EHRMANN, MD PhD","SUB_INVESTIGATOR",{"name":79,"role":77,"phone":30,"phoneExt":30,"email":30},"Adrien LEMAIGNEN, MD PhD",{"type":81,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[83,86,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116,118,120,122,125,128,130,132,134,136,138],{"name":84,"class":85},"University Hospital, Angers","OTHER_GOV",{"name":87,"class":6},"Centre Hospitalier Universitaire de Besancon",{"name":89,"class":6},"University Hospital, Bordeaux",{"name":91,"class":6},"University Hospital, Brest",{"name":93,"class":6},"Centre Hospitalier Universitaire Dijon",{"name":95,"class":6},"University Hospital, Grenoble",{"name":97,"class":6},"University Hospital, Lille",{"name":99,"class":6},"University Hospital, Limoges",{"name":101,"class":6},"Hospices Civils de Lyon",{"name":103,"class":6},"University Hospital, Montpellier",{"name":105,"class":6},"Nantes University Hospital",{"name":107,"class":6},"Centre Hospitalier Universitaire de Nice",{"name":109,"class":6},"Hospital Avicenne",{"name":111,"class":6},"Henri Mondor University Hospital",{"name":113,"class":6},"Hopital Foch",{"name":115,"class":6},"Hôpital Necker-Enfants Malades",{"name":117,"class":6},"Pitié-Salpêtrière Hospital",{"name":119,"class":6},"Poitiers University Hospital",{"name":121,"class":6},"Reims University hospital",{"name":123,"class":124},"Ohre Pharma","UNKNOWN",{"name":126,"class":127},"Aerogen","INDUSTRY",{"name":129,"class":127},"Wako Diagnostics",{"name":131,"class":127},"Cape Cod Incorporated",{"name":133,"class":85},"Institut National de la Santé Et de la Recherche Médicale, France",{"name":135,"class":124},"Tours university",{"name":137,"class":6},"Amiens University Hospital",{"name":139,"class":6},"Rennes University Hospital","100584715","phase-1-casponeb-efficacy-and-safety-of-caspofungin-aerosols-for-the-curative-treatment-of-pneumocystis-pneumonia-100584715",false,"NCT06892951","CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia","Phase I\u002FII Safety lead-in Randomized Blind Placebo-controlled Clinical Trial: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia in Adjunction of Conventional Systemic Antifungal Therapy","CaspoNEB","Inclusion criteria:\n\n* Male and female ≥18 years\n* Medical management of Pneumocystis pneumonia based on :\n\n  * Microbiological diagnosis of Pneumocystis pneumonia\n  * Respiratory support (oxygen therapy or ventilatory assistance)\n  * Systemic co-trimoxazole therapy or systemic second-line anti-Pneumocystis salvage therapy (switch to another anti-Pneumocystis drug is possible, but should be notified) (initiated within 48 hours or less before enrolment)\n* Person affiliated to a French social security system or equivalent\n* Written informed consent obtained from the participant or, if the patient is not able to give consent from representative (trusted person, family member) or if the delay in obtaining the consent is assumed not compatible with the enrollment requirements, a temporary approval can be obtained from the investigator. In all cases, the patient's written informed consent will have to be obtained as soon as possible.\n\nNon-inclusion criteria:\n\n* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship). Pregnancy test to be performed in all women from 15 to 45 years old who have not had an ovariectomy.\n* Other indication(s) for systemic administration of an echinocandin drug\n* Known allergy to echinocandin drugs\n* Absolute contraindication to aerosol therapy\n* Concomitant co-infection at time of diagnosis (except HIV infection)\n* Severe liver impairment (i.e. documented severe liver cirrhosis (Child C), or Factor-V protein \\\u003C 50% and\u002For INR for prothrombin time of blood coagulation \\> 1.5)\n* history of toxic epidermal necrosis (TEN) and Steven-Johnson syndrome (SJS)\n* Participation in other pharmacological study that focuses on echinocandins and\u002For anti-infectious aerosol therapy or other anti-pneumocystis treatment\n* Participation in a trial with an investigational product known to have pulmonary toxicity or of which the safety is not known","ALL","18 Years",{"count":151,"type":152},100,"ESTIMATED","INTERVENTIONAL",[155,156],"PHASE1","PHASE2","To assess the efficacy of administrating daily caspofungin aerosols versus placebo for seven days, in adjunction of conventional systemic antifungal therapy during curative treatment of Pneumocystis pneumonia, on the clinical outcome at the end of the nebulized therapy, in order to support a \"GO \u002F NO GO\" decision towards a phase III trial of nebulized caspofungin in those patients.",[159,160,161],"Pneumocystis Pneumonia","Pneumocystis Jirovecii Infection","Pneumocystis Infections",[163,164,165,166,167,168,169,170],"ventilation","Pneumocystis","caspofungin","echinocandin","aerosol","inhalation","nebulization","interstitial pneumonia","NOT_YET_RECRUITING","2025-03-17",{"date":174,"type":175},"2025-03-25","ACTUAL",{"date":177,"type":152},"2025-06",{"date":179,"type":152},"2028-12",{"name":5,"class":6},1]