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

Phase 4

Recruiting

• Conditions: Autoimmune Diseases; Pneumonia, Pneumocystis; Connective Tissue Disease; Autoimmune Inflammatory Rheumatic Disease; Prevention
• Interventions: Drug: Trimethoprim/Sulfamethoxazole

• Registration Number: NCT06499233
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-06
• Study First Posted: 2024-07-12
• Study Start: 2024-07-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2026-07-20
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMP/SMX (with PJP high risk)	Trimethoprim/Sulfamethoxazole	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.
TMP/SMX (with PJP low-risk)	Trimethoprim/Sulfamethoxazole	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China