[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604676":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":39,"collaborators":30,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":30,"enrollmentInfo":53,"targetDuration":30,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":30,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":30},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","PLACEBO_COMPARATOR","Control Group",[13],"Drug: Saline (0.9%, sterile, for infusion)",{"label":15,"type":16,"description":15,"interventionNames":17},"Low dose steroids","EXPERIMENTAL",[18],"Drug: Low Dose Corticosteroids",{"label":20,"type":16,"description":21,"interventionNames":22},"Moderate dose steroids","moderate dose steroids",[23],"Drug: Moderate dose corticosteroids",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Saline (0.9%, sterile, for infusion)","Saline for control",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Low Dose Corticosteroids","Methylprednisolone 0.5mg\u002Fkg ivgtt qd",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Moderate dose corticosteroids","Methylprednisolone 1.0mg\u002Fkg ivgtt qd",[20],{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Qingyuan Zhan","Director","100604676","phase-3-corticosteroids-for-pjp-in-non-hiv-immunocompromised-adults-100604676",false,"NCT07152613","Corticosteroids for PJP in Non-HIV Immunocompromised Adults","An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Pneumocystis Jirovecii Pneumonia (PJP) in Non-HIV Immunocompromised Patients","CAPSTONE-PJP","Inclusion Criteria:\n\nAge ≥ 18 years.\n\nAdmission to the Intensive Care Unit (ICU).\n\nMeeting the diagnostic criteria for community-acquired pneumonia (CAP).\n\nMeeting at least one of the major diagnostic criteria for severe pneumonia:\n\n(i) Requirement for endotracheal intubation and mechanical ventilation;\n\n(ii) Septic shock requiring vasopressor therapy after adequate fluid resuscitation.\n\nOr simultaneously fulfilling three of the minor criteria:\n\n(i) Respiratory rate ≥ 30 breaths\u002Fmin;\n\n(ii) PaO₂\u002FFiO₂ ≤ 250 mmHg;\n\n(iii) Multilobar infiltrates;\n\n(iv) Altered mental status and\u002For disorientation;\n\n(v) Blood urea nitrogen ≥ 20 mg\u002FdL (7.12 mmol\u002FL);\n\n(vi) Leukopenia (white blood cell count \\\u003C 4 × 10⁹\u002FL);\n\n(vii) Thrombocytopenia (platelet count \\\u003C 100 × 10⁹\u002FL);\n\n(viii) Hypothermia (core temperature \\\u003C 36 °C);\n\n(ix) Hypotension (systolic blood pressure \\\u003C 90 mmHg) requiring aggressive fluid resuscitation.\n\nConfirmed PJ etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for Pneumocystis jirovecii in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid).\n\nSevere community-acquired pneumonia (SCAP) patients admitted to the emergency department\u002Fward\u002FICU due to respiratory failure within \\\u003C 72 hours.\n\nSigned informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnant or breastfeeding women.\n* HIV infection.\n* No targeted PJP therapy administered or therapy not according to standard protocol.\n* Diagnosis of PJP \\>7 days prior to MICU admission.\n* Use of corticosteroids for PJP prior to MICU admission.\n* Requirement for high-dose baseline corticosteroid therapy for other conditions (prednisone ≥ 0.5 mg\u002Fkg\u002Fday or equivalent).\n* Any contraindication to corticosteroid use as judged by the investigator (e.g., severe concurrent infectious disease, severe gastrointestinal bleeding).\n* Discharge or death within 48 hours after intervention.\n* Participation in other clinical studies or refusal to participate in this study.","ALL","18 Years",{"count":54,"type":55},240,"ESTIMATED","INTERVENTIONAL",[58],"PHASE3","Pneumocystis jirovecii pneumonia (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and society. To address this medical challenge, our institution is conducting a study aimed at lowering PJP-related mortality. Specifically, we are performing an adaptive, randomized, open-label controlled trial in patients with severe PJP. The primary objective of this study is to scientifically evaluate the efficacy and safety of adjunctive corticosteroids at different dosages, in addition to early standard supportive care, for reducing mortality in severe PJP",[61],"Pneumocystis Jiroveci Pneumonia",[63,64,65,66],"community-acquired pneumonia","Pneumocystis jiroveci","non-HIV","corticosteroids","NOT_YET_RECRUITING","2025-09-02",{"date":70,"type":71},"2025-09-09","ACTUAL",{"date":73,"type":55},"2025-09-08",{"date":75,"type":55},"2027-12-31",{"name":41,"class":6}]