Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients Wi… (NCT06499233) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
China800 participantsStarted 2024-07-20
Plain-language summary
This is an open-labeled, prospective clinical study aims at collecting and analyzing baseline characteristics of autoimmune inflammatory rheumatic disease (AIIRD) patients receiving sulfanilamide for preventive purposes, as well as subsequent follow-up data, in order to assess the efficacy and safety of the medication. Additionally, through a stratified analysis of risk factors, the investigators aim to identify the AIIRD population that would benefit most from preventive medication based on a favorable benefit-risk ratio.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient was diagnosed with AIIRD according to the International Classification of Diseases and had received steroids or immunosuppressive therapy;
✓. The patient had not received standard PJP treatment before enrollment, including the first-line treatment drug TMP/SMZ, or other second-line treatment drugs (including Pentamidine, Atorvastatin, Caspofungin, etc.);
✓. The patient was at least 18 years old at the time of enrollment;
Exclusion criteria
✕. Serious health problems or diseases, including (but not limited to) the following: severe liver damage (ALT, AST elevated above normal value by more than 5 times), severe renal insufficiency (GFR \< 30mL/min or Scr \> 445umol/L), severe myelosuppression (Hb \< 65g/L, PLT \< 25×10\^9/L or neutrophils \< 0.5×10\^9/L);
✕. Screening test indicates infection with human immunodeficiency virus (HIV), history of lymphomatous hyperplasia of the lymphatic tissue or any malignant tumor of any organ system within the past 5 years, or history of organ transplantation;
✕. Participants with a history of allergy to sulfonamide drugs, megaloblastic anemia due to folate deficiency;
✕. Any medical or psychological condition that the investigator believes would interfere with the participant's ability to comply with the protocol or complete the study;
✕. Patients who refuse to comply with the requirements of this study and complete the study;
✕. Any other situation that the investigator considers unsuitable for participation in the study (for reasons including but not limited to management reasons).