[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumocystis-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumocystis-infections":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100427823","phase-3-low-dose-trimethoprim-sulfamethoxazole-for-the-treatment-of-pneumocystis-jirovecii-pneumonia-100427823",false,"NCT04851015","Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia","LOW-DOSE","Inclusion Criteria:\n\n* 18 years or older\n* Immunocompromised (including but not limited to HIV, solid organ transplant, solid tumors, hematological stem cell transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies\n* Presentation to a day hospital, emergency department, or admitted to hospital\n* Proven or probable diagnosis of PCP using an adapted version of the 2021 EORTC\u002FMSGERC criteria.\n\nExclusion Criteria:\n\n* Previous severe adverse reaction to TMP-SMX, any sulfa drug, or any component of formulation\n* Compliant with PCP prophylaxis for ≥4 weeks with TMP-SMX at enrollment\n* More than 96 hours of any therapy for PCP\n* Hepatic impairment marked by alanine aminotransferase levels ≥5 times the upper limit of normal\n* Known G6PD deficiency\n* Known diagnosis of porphyria\n* Known pregnancy or breastfeeding (as per Health Canada)\n* Unable to provide informed consent and no available healthcare proxy (with ethics approval for deferred consent in cases of critical illness); refusal of consent; no reliable means of outpatient contact (telephone\u002Femail\u002Ftext);\n* Previously enrolled","ALL","18 Years","100 Years",{"count":20,"type":21},416,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Pneumocystis jirovecii pneumonia (PCP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg\u002Fkg\u002Fday of TMP, is associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX.\n\nReduced treatment doses of TMP-SMX for PCP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg\u002Fkg\u002Fday of TMP) compared to the standard-of-care (15 mg\u002Fkg\u002Fday) among patients with PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay.",[27,28,29,30,31,32,33,34],"Pneumocystis","Pneumocystis Pneumonia","Pneumocystis Jirovecii Infection","Pneumocystis Infections","Pneumocystis Carinii Infection","Pneumocystosis; Pneumonia (Etiology)","Pneumocystis Carinii; Infection, Resulting From HIV Disease","Pneumocystosis Associated With AIDS",[27,36,37,38,39,40],"PCP","PJP","immunosuppressed","HIV","TMP-SMX","RECRUITING","2026-02-18",{"date":44,"type":45},"2026-02-20","ACTUAL",{"date":47,"type":45},"2025-11-28",{"date":49,"type":21},"2030-12-31",{"name":51,"class":52},"Todd C. Lee MD MPH FIDSA","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":53},"100584715","phase-1-casponeb-efficacy-and-safety-of-caspofungin-aerosols-for-the-curative-treatment-of-pneumocystis-pneumonia-100584715","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",{"count":63,"type":21},100,[65,66],"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.",[28,29,30],[70,27,71,72,73,74,75,76],"ventilation","caspofungin","echinocandin","aerosol","inhalation","nebulization","interstitial pneumonia","NOT_YET_RECRUITING","2025-03-17",{"date":80,"type":45},"2025-03-25",{"date":82,"type":21},"2025-06",{"date":84,"type":21},"2028-12",{"name":86,"class":52},"University Hospital, Tours"]