Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia (PJP) in Patients With Autoimmune Inflammatory Rheumatic Disease (AIIRD)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Lingli Dong
tjhdongll@163.com
02783665519
Backup
Shaozhe Cai
540361903@qq.com
02783665518
Time Frame
Start Date:2024-07-20
Estimated Completion Date:2026-12-31
Participants
Target number of participants:800
Treatments
Experimental: TMP/SMX (with PJP high risk)
AIIRD patients who have PJP high risk and receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment; Drug intervention: Patients receive Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis.
No_intervention: no TMP/SMX (with PJP high risk)
AIIRD patients who have PJP high risk and do not receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment.
Experimental: TMP/SMX (with PJP low-risk)
AIIRD patients who have PJP low risk and receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment; Drug intervention: Patients receive Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis.
No_intervention: no TMP/SMX (with PJP low-risk)
AIIRD patients who have PJP low risk and do not receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment.