Study on the Safety and Effectiveness of Preventive Treatment for Pneumocystis Jirovecii Pneumonia in Adults with Autoimmune Inflammatory Rheumatic Diseases

What this Trial Is About

Researchers are evaluating the use of prophylactic treatment with TrimethoprimSulfamethoxazole TMPSMX to prevent Pneumocystis Jirovecii Pneumonia PJP in patients with autoimmune inflammatory rheumatic diseases AIIRD. This open-label, prospective clinical study aims to collect baseline data and follow-up information to assess the safety and effectiveness of TMPSMX for prevention. The study also seeks to identify which AIIRD patients might benefit most from this preventive treatment based on risk factors and benefit-risk balance. Participants are divided into four groups based on their PJP risk level and whether they receive TMPSMX prophylaxis. Those in the treatment groups receive 480 mg of TMPSMX orally every day for at least 28 days, with adjustments made by clinicians depending on individual patient condition, drug tolerance, and willingness. Patients who do not receive prophylaxis serve as comparison groups to help evaluate treatment outcomes. During the study, researchers will monitor participants for PJP infection at 6 and 12 months, as well as track adverse drug reactions related to TMPSMX, PJP-related deaths, and deaths from any cause. Participants will undergo regular assessments to gather data on these outcomes. The study will provide information on the safety and efficacy of TMPSMX prophylaxis in AIIRD patients over the course of their participation.

Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease