Actively Recruiting
Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
Led by Tongji Hospital · Updated on 2024-10-01
800
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with autoimmune inflammatory rheumatic disease and received steroids or immunosuppressive therapy
- Have not received standard Pneumocystis Jirovecii Pneumonia treatment before, including Trimethoprim/Sulfamethoxazole or other second-line drugs
- At least 18 years old at enrollment
You will not qualify if you...
- Severe liver damage (ALT, AST more than 5 times above normal)
- Severe kidney failure (GFR < 30 mL/min or serum creatinine > 445 umol/L)
- Severe myelosuppression (hemoglobin < 65 g/L, platelets < 25 x 10^9/L, or neutrophils < 0.5 x 10^9/L)
- HIV infection, lymphoma history, any cancer within past 5 years, or organ transplant history
- Allergy to sulfonamide drugs or folate deficiency megaloblastic anemia
- Pregnant or breastfeeding women
- Any medical or psychological condition affecting protocol compliance
- Refusal to comply with study requirements
- Any other situation deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 43003
Actively Recruiting
Research Team
L
Lingli Dong
CONTACT
S
Shaozhe Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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