Pneumonia, Pneumocystis, Autoimmune Inflammatory Rheumatic Disease, Autoimmune Diseases, Connective Tissue Disease, Prevention
Conditions
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 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.
Interventions
Patients 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).
Sponsors
Tongji Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient was diagnosed with AIIRD according to the International Classification of Diseases and had received steroids or immunosuppressive therapy; 2. 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.); 3. The patient was at least 18 years old at the time of enrollment;
Exclusion criteria
1. 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); 2. 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; 3. Participants with a history of allergy to sulfonamide drugs, megaloblastic anemia due to folate deficiency; 4. Pregnant and lactating women; 5. 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; 6. Patients who refuse to comply with the requirements of this study and complete the study; 7. Any other situation that the investigator considers unsuitable for participation in the study (for reasons including but not limited to management reasons).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with PJP infection | 6 months, 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| TMP/SMZ related adverse drug reactions | 6 months, 12 months | 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 | 6 months, 12 months | PJP-related mortality at the end of month 6. |
| All cause mortality | 6 months, 12 months | All cause mortality |
Countries
China
Contacts
Primary ContactLingli Dong
Backup ContactShaozhe Cai
Outcome results
None listed