[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumocystis-carinii-infection-resulting-from-hiv-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumocystis-carinii-infection-resulting-from-hiv-disease":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,89],{"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":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100620398","phase-4-positioning-second-line-therapies-for-pneumocystis-jirovecii-pneumonia-pcp-alternatives-100620398","NCT07357103","Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)","Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives) [A Branch of the Initial Treatment Domain of the SPIRIT-PCP Platform]","SPIRIT-ALT","Inclusion Criteria:\n\n* Immunocompromised patients (including but not limited to HIV, solid organ transplant, solid tumors, hematological transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies) in an emergency department, cliinic, or hospital\n\n  * Age ≥18 years\n  * Proven or probable Pneumocystis jirovecii pneumonia\n  * Inability to receive trimethoprim-sulfamethoxazole due to contraindication, intolerance, toxicity, or treatment failure\n  * Immunocompromised status\n  * Ability to provide informed consent (or per local regulations)\n\nWhile participants may be enrolled in multiple domains of the SPIRIT-PCP Platform over time (if they are eligible and a domain is active), they may only be enrolled to single question once (e.g., they can be part PCP Alternatives and an eventual secondary prophylaxis domain; however, if they have a recurrence, they cannot be included in PCP Alternatives again).\n\nExclusion Criteria:\n\n* The Platform will exclude: patients where we are unable to obtain informed consent, where patients or their proxy have declined to consent, where the treating team has declined participation, where follow up cannot be reliably obtained (e.g., lack of means of communication, patient non-resident of jurisdiction), where treatment with antibiotics is not in keeping with a patient's advanced care directives, and where death is deemed imminent (\\\u003C48h) as determined by the treating team and site investigator.\n\nClinical:\n\n1. Previous severe adverse reaction or hypersensitivity to clindamycin, primaquine, or atovaquone (mild-moderate PCP) or to clindamycin, primaquine, or pentamidine (severe PCP);\n2. More than 7 calendar days of any therapy for PCP (no more than 4 can involve a study drug).\n3. Known pregnancy or breastfeeding (pregnancy test will be offered)\n\n   Drug specific exclusion criteria:\n4. For clindamycin-primaquine:\n\n   1. Known G6PD deficiency OR family history of G6PD deficiency without excluding by testing\\*\n   2. Known diagnosis of porphyria\n   3. Concomitant use of methotrexate or cyclophosphamide which cannot be held \\*G6PD deficiency is an X-linked recessive genetic disease. Female patients without a family history are very unlikely to have this disease and so therapy can start while waiting for the test in the absence of a family history. Male patients should wait for test results prior to receiving primaquine even if they do not have a family history. For those without G6PD testing at diagnosis, it is a reasonable standard of care to order testing.\n5. For pentamidine:\n\n   1. Absence of adequate intravenous access as determined by treating team and site investigator. In the event of loss of IV, up to 2 consecutive doses can be given intramuscularly if the patient is not systemically anticoagulated and does not have a coagulopathy.\n   2. Hypotension defined as systolic blood pressure below 90mmHg without pharmacologic support\n   3. Personal history of Torsade de Pointes or presence of a corrected QTc of greater than 490ms on ECG on date of enrollment\n6. For atovaquone:\n\n   1. Receipt of PCP Prophylaxis (≥3 doses per week) for ≥ 4 weeks with atovaquone\n   2. inability to tolerate atovaquone with a meal or enteral feeding (e.g., prolonged NPO status is an exclusion as atovaquone must be taken with food for proper absorption)\n   3. Concurrent use of rifampin, rifabutin, or tetracycline (that cannot be stopped)\n   4. Reduced gastric absorption (patient must not have a medical condition which the treating team and\u002For site investigator believes will interfere with atovaquone absorption, e.g., total gastrectomy)\n\nAdministrative:\n\n1\\. Trial site not participating in PCP Alternatives branch of the initial therapy domain",{"count":20,"type":21},[64],"PHASE4","The usual first treatment for Pneumocystis jirovecii pneumonia (PCP) is an antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX). However, some patients cannot take this medication because of allergies, side effects, or lack of response.\n\nThis study asks the question:\n\nWhen TMP-SMX cannot be used, which alternative treatment for PCP provides the best balance of effectiveness and safety?",[27,67,31,33,68,29,34,32],"Pneumocystis Infection","Pneumocystis Jirovecii Pneumonia",[36,70,71,72,73,74,75,39,76,77,78],"Pneumocystis jirovecii pneumonia","PCP Alternatives","Clindamycin","Pentamidine","Primaquine","Atovaquone","Non-HIV","Immunocompromised host","Randomized Control Trial","NOT_YET_RECRUITING","2026-01-15",{"date":82,"type":45},"2026-01-21",{"date":84,"type":21},"2026-03",{"date":86,"type":21},"2029-09",{"name":88,"class":52},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":53},"100618235","phase-4-how-long-should-we-give-steroids-for-patients-with-severe-pcp-100618235","NCT07328984","How Long Should we Give Steroids for Patients With Severe PCP","How Long Should we Give Steroids for Patients With Severe PCP (HOW LONG)","HOW LONG","Inclusion Criteria:\n\n* Age ≥18 years\n* Proven or probable Pneumocystis jirovecii pneumonia\n* Severe PCP requiring supplemental oxygen (e.g., ≥4 L\u002Fmin or ≥35% FiO₂ to maintain SpO₂ ≥94%)\n* Planned or receiving adjunctive systemic corticosteroid therapy for severe PCP\n* Clinical recovery by day 10 of steroid therapy: breathing room air for ≥6 hours\n* Able to provide informed consent (or per local requirements)\n\nExclusion Criteria:\n\n* Persistent hypoxemia or ongoing oxygen requirement at day 10\n* Clinical deterioration prior to randomization\n* Treating clinician determines steroids must be continued or stopped immediately for medical reasons\n* Anticipated death within 48 hours\n* Inability or unwillingness to complete follow-up through day 180",{"count":20,"type":21},[64],"The HOW LONG trial is an international, multicenter, Phase IV randomized clinical trial evaluating the optimal duration of adjunctive systemic corticosteroids in immunocompromised adults with severe Pneumocystis jirovecii pneumonia (PCP) who demonstrate early clinical recovery. Participants who no longer require supplemental oxygen by day 10 of corticosteroid therapy are randomized to discontinue corticosteroids at day 10 (or hospital discharge, if earlier) versus continue corticosteroids for a total of 21 days. The trial assesses whether earlier discontinuation reduces steroid-related complications while maintaining clinical outcomes.",[28,27,29,101,33,34,32],"Pneumocystis Jiroveci Pneumonia",[36,103,104,78,77,39,76,70],"Systemic Corticosteroids","De-escalation of Therapy","2025-12-27",{"date":107,"type":45},"2026-01-09",{"date":109,"type":21},"2026-01-30",{"date":111,"type":21},"2029-06",{"name":88,"class":52}]