About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Trimethoprim/Sulfamethoxazole
DrugPatients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis; Treatment duration: at least 28 days, adjusted by the clinician based on the severity of the patient's condition, the patient's tolerance to the drug and treatment willingness).
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with PJP infection
Defined as documentation/diagnosis of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PJP.
Secondary outcomes
TMP/SMZ related adverse drug reactions
Symptoms and signs that may be related to adverse drug reactions during treatment (such as nausea, vomiting, anorexia, jaundice, rashes and hives, and shock); incidence, duration and severity of adverse events
PJP-related mortality
PJP-related mortality at the end of month 6.
All cause mortality
All cause mortality
Sponsors and contacts
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