[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427823":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":39,"locations":46,"responsibleParty":72,"collaborators":67,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":67,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":102,"overallStatus":49,"whyStopped":67,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced dose TMP-SMX","EXPERIMENTAL","Trimethoprim-Sulfamethoxazole at a total dose of 10mg\u002Fkg\u002Fday. Oral or intravenous drug will be administered at discretion of treating team. This will be given as a dose of 10mg\u002Fkg\u002Fday open label with additional placebo tablets or intravenous placebo solution given to simulate 15mg\u002Fkg\u002Fday. All doses will be adjusted for obesity and renal function.",[13],"Drug: trimethoprim-sulfamethoxazole",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard dose TMP-SMX","ACTIVE_COMPARATOR","Trimethoprim-Sulfamethoxazole at a total dose of 15mg\u002Fkg\u002Fday. Oral or intravenous drug will be administered at discretion of treating team. This will be given as 10mg\u002Fkg\u002Fday open label plus an extra masked 5mg\u002Fkg\u002Fday of tablets or intravenous solution. All doses will be adjusted for obesity and renal function.",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","trimethoprim-sulfamethoxazole","10mg\u002Fkg\u002Fday of TMP component",[9],[26],"Reduced dose",{"type":21,"name":22,"description":28,"armGroupLabels":29,"otherNames":30},"15mg\u002Fkg\u002Fday of TMP component",[15],[31],"Standard dose",[33,37],{"name":34,"affiliation":35,"role":36},"Emily G McDonald, MD MSc","Research Institute of the McGill University Health Centre","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Todd C Lee, MD MPH FIDSA",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Babykumari Chitramuthu, PhD","CONTACT","514-934-1934","23730","babykumari.chitramuthu@muhc.mcgill.ca",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)","RECRUITING","Montreal","Quebec","H4A3J1","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-73.58781,45.50884,{"lat":59,"lon":58},[62,63,66,68,69],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":64,"role":42,"phone":43,"phoneExt":44,"email":65},"Kristen Moran","kristen.moran@mail.mcgill.ca",{"name":34,"role":36,"phone":67,"phoneExt":67,"email":67},null,{"name":38,"role":36,"phone":67,"phoneExt":67,"email":67},{"name":70,"role":71,"phone":67,"phoneExt":67,"email":67},"Cheng P Matthew, MD","SUB_INVESTIGATOR",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":67,"oldOrganization":67},"SPONSOR_INVESTIGATOR","Todd C. Lee MD MPH FIDSA","Professor of Medicine","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":87,"type":88},416,"ESTIMATED","INTERVENTIONAL",[91],"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.",[94,95,96,97,98,99,100,101],"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",[94,103,104,105,106,107],"PCP","PJP","immunosuppressed","HIV","TMP-SMX","2026-02-18",{"date":110,"type":111},"2026-02-20","ACTUAL",{"date":113,"type":111},"2025-11-28",{"date":115,"type":88},"2030-12-31",{"name":74,"class":6},1]