Status:
RECRUITING
Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
Lead Sponsor:
Tongji Hospital
Conditions:
Pneumonia, Pneumocystis
Autoimmune Inflammatory Rheumatic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
- Pregnant and lactating women;
- 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).
Key Trial Info
Start Date :
July 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06499233
Start Date
July 20 2024
End Date
December 31 2026
Last Update
October 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tongji Hospital
Wuhan, Hubei, China, 43003