Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia (PJP) in Patients With Autoimmune Inflammatory Rheumatic Disease (AIIRD)
Overview
- Phase
- Phase 4
- Intervention
- Trimethoprim/Sulfamethoxazole
- Conditions
- Pneumonia, Pneumocystis
- Sponsor
- Tongji Hospital
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Number of participants with PJP infection
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Lingli Dong
Professor
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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).
Arms & Interventions
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.
Intervention: Trimethoprim/Sulfamethoxazole
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.
Intervention: Trimethoprim/Sulfamethoxazole
Outcomes
Primary Outcomes
Number of participants with PJP infection
Time Frame: 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 Outcomes
- TMP/SMZ related adverse drug reactions(6 months, 12 months)
- PJP-related mortality(6 months, 12 months)
- All cause mortality(6 months, 12 months)