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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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).

Первичные конечные точки

• Number of participants with PJP infection [Срок оценки: 6 months, 12 months]

Вторичные конечные точки (3)

• TMP/SMZ related adverse drug reactions [Срок оценки: 6 months, 12 months]
• PJP-related mortality [Срок оценки: 6 months, 12 months]
• All cause mortality [Срок оценки: 6 months, 12 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT06499233 · TJ-IRB20231250

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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