[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumocystis-jirovecii-pneumonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumocystis-jirovecii-pneumonia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100638170","phase-4-low--vs-standard-dose-tmp-smx-for-prevention-of-pneumocystis-pneumonia-after-kidney-transplantation-100638170",false,"NCT07619027","Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation","A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation","TMP-SMX PJP","Inclusion Criteria:\n\n-Age: Between 18 and 70 years old. Transplant Status: Recipients of a first-time kidney transplant. Renal Function: Serum creatinine levels have stabilized with a creatinine -----clearance (CrCl) \\> 30 mL\u002Fmin.\n\nConsent \\& Compliance: Voluntarily agree to participate in this study, are capable of cooperating with the investigators, and have signed the informed consent form.\n\nExclusion Criteria:\n\n-HIV Infection: Known HIV positive status. Drug Allergy: History of allergy or hypersensitivity to TMP-SMX (Trimethoprim-Sulfamethoxazole).\n\nPrior PJP: History of Pneumocystis jirovecii pneumonia (PJP) before transplantation.\n\nG6PD Deficiency: Glucose-6-phosphate dehydrogenase deficiency. Multi-organ Transplant: Recipients of multi-organ transplants. Active Infection: Presence of other severe concurrent infections. Immune System Disorders: Concomitant diseases affecting the immune system (e.g., malignancies\u002Ftumors, connective tissue diseases, hematological system diseases).\n\nPregnancy: Pregnant women. Anemia: Megaloblastic anemia. Non-compliance: Inability to adhere to regular follow-up schedules or poor compliance.","ALL","18 Years","70 Years",{"count":21,"type":22},1084,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients.\n\nParticipants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications.\n\nParticipants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.",[28,29],"Pneumocystis Jirovecii Pneumonia","Kidney Transplantation",[31,32,33,34],"PJP prophylaxis","Kidney transplant recipients","Trimethoprim-Sulfamethoxazole","Low-dose","NOT_YET_RECRUITING","2026-05-26",{"date":38,"type":39},"2026-06-01","ACTUAL",{"date":41,"type":22},"2026-06",{"date":43,"type":22},"2030-06",{"name":45,"class":46},"Anhui Provincial Hospital","OTHER_GOV",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"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":56,"type":22},416,[25],"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?",[60,61,62,63,28,64,65,66],"Pneumocystis","Pneumocystis Infection","Pneumocystis Carinii Infection","Pneumocystis Carinii; Infection, Resulting From HIV Disease","Pneumocystis Jirovecii Infection","Pneumocystosis Associated With AIDS","Pneumocystosis; Pneumonia (Etiology)",[68,69,70,71,72,73,74,75,76,77,78],"PCP","Pneumocystis jirovecii pneumonia","PCP Alternatives","Clindamycin","Pentamidine","Primaquine","Atovaquone","HIV","Non-HIV","Immunocompromised host","Randomized Control Trial","2026-01-15",{"date":81,"type":39},"2026-01-21",{"date":83,"type":22},"2026-03",{"date":85,"type":22},"2029-09",{"name":87,"class":88},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER"]