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Recruiting NCT06499233

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

Phase IV Interventional Pneumonia, Pneumocystis Autoimmune Inflammatory Rheumatic Disease Autoimmune Diseases Connective Tissue Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trimethoprim/Sulfamethoxazole.
Who it may be relevant to
Registry conditions: Pneumonia, Pneumocystis, Autoimmune Inflammatory Rheumatic Disease, Autoimmune Diseases, Connective Tissue Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Trimethoprim/Sulfamethoxazole
    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).

Primary outcome measures

  • Number of participants with PJP infection [Time frame: 6 months, 12 months]
Secondary outcome measures (3)
  • TMP/SMZ related adverse drug reactions [Time frame: 6 months, 12 months]
  • PJP-related mortality [Time frame: 6 months, 12 months]
  • All cause mortality [Time frame: 6 months, 12 months]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Tongji Hospital — Wuhan

Identifiers

NCT: NCT06499233 · TJ-IRB20231250

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗