Preventive treatment for pneumonia in patients with autoimmune diseases

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

This study is testing if a common antibiotic can help prevent a specific type of pneumonia in people with autoimmune diseases.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06499233 on ClinicalTrials.gov

What this trial studies

This open-label, prospective clinical study aims to evaluate the efficacy and safety of trimethoprim/sulfamethoxazole as a preventive treatment for Pneumocystis jirovecii pneumonia in patients diagnosed with autoimmune inflammatory rheumatic diseases. The study will collect and analyze baseline characteristics of participants receiving this medication and follow up to assess outcomes. Additionally, a stratified analysis will identify which patients are most likely to benefit from this preventive approach based on their risk factors.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with autoimmune inflammatory rheumatic diseases who are receiving steroids or immunosuppressive therapy.

Not a fit: Patients with severe health issues or those who have previously received standard Pneumocystis pneumonia treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of pneumonia in patients with autoimmune inflammatory rheumatic diseases.

How similar studies have performed: Other studies have explored preventive treatments for pneumonia in immunocompromised patients, showing promising results, but this specific approach is less commonly tested.

Eligibility criteria

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).

Where this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Lingli Dong — Tongji Hospital
• Study coordinator: Lingli Dong

Conditions Pneumonia, Pneumocystis; Autoimmune Inflammatory Rheumatic Disease; Autoimmune Diseases; Connective Tissue Disease; Prevention