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Идёт набор NCT07231770

Sulfamethoxazole Prophylaxis Duration After Renal Transplantation

Без фазы С лечением Fever Chest Tightness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Time-driven dosing.
Кому может быть актуально
Состояния в реестре: Fever, Chest Tightness. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Controlled Study on the Prophylaxis of Pneumocystis Jirovecii Pneumonia With Fixed-dose Compound Sulfamethoxazole Tablets of Different Maintenance Durations After Renal Transplantation

Обзор

Renal transplantation is the most ideal and effective treatment for end-stage renal disease. Pneumocystis jirovecii pneumonia (PJP) is one of the most common pulmonary infections after renal transplantation, with high morbidity and mortality that seriously affects patients' prognosis and survival. PJP can be prevented with drugs, and trimethoprim-sulfamethoxazole (TMP-SMX) is the first-choice prophylactic agent. However, there is no clear definition of the prophylactic course of TMP-SMX in domestic and international guidelines. Most of the prophylactic durations for PJP are based on the clinical experience of physicians, ranging from 6 to 12 months across different transplant centers. Multiple studies have shown that some patients still develop PJP more than one year after renal transplantation. Previous research by our team found that PJP has a peak incidence around 9 months after renal transplantation, with a second peak occurring between 10 and 15 months. This study aims to adopt a single-center, randomized, parallel-controlled trial design, planning to enroll 450 patients after renal transplantation. It will investigate the impact of different prophylactic courses of TMP-SMX on the incidence of PJP, and explore whether long-term prophylaxis is more reasonable and effective than short-term prophylaxis. Meanwhile, during follow-up, the peak serum concentration of SMZ in patients will be measured to analyze the relationship between SMZ serum concentration and the occurrence of PJP as well as adverse reactions. A clinical prediction model will be constructed to reveal the effective concentration range of TMP-SMX for prophylactic use. This will further optimize the prophylactic regimen, provide practical guidance for clinical practice, reduce the morbidity and mortality of PJP, and improve prognosis.

Вмешательства

  • Другое Time-driven dosing
    The total sample size required for the study is 450 cases. Patients will then be screened for enrollment according to the inclusion and exclusion criteria, and randomly assigned to Groups A, B, and C in a 1:1:1 ratio, with 150 patients in each group. Group A will receive TMP-SMX prophylaxis against PJP for 6 months, while Groups B and C will each receive TMP-SMX prophylaxis against PJP for 12 months.

Первичные конечные точки

  • Incidence of PJP [Срок оценки: 18 months after the end of treatment]
Вторичные конечные точки (1)
  • adverse reaction rate [Срок оценки: 18 month]

Критерии участия

Diagnostic Criteria for PJP (meeting one of the following criteria is sufficient):

  • Detection of Pneumocystis jirovecii via sputum Gomori methenamine silver (GMS) stain.
  • According to guidelines/consensus: Positive direct immunofluorescence assay and/or positive polymerase chain reaction (PCR) assay on induced sputum or bronchoalveolar lavage fluid (BALF) specimens.
  • Detection of Pneumocystis jirovecii strains in sputum, blood, or bronchoalveolar lavage fluid (BALF) by metagenomic next-generation sequencing (mNGS).

Критерии включения

  • Subjects must meet all the following conditions to be enrolled: (1) Age: 18-70 years old; (2) Post-renal transplantation; (3) Voluntarily participate in this clinical study, be able to cooperate with researchers to conduct the study, and sign the informed consent form.

Критерии исключения

  • Criteria: Subjects with any of the following conditions shall be excluded from the trial: (1) HIV-positive; (2) History of TMP-SMX allergy; (3) Glucose-6-phosphate dehydrogenase (G6PD) deficiency; (4) Megaloblastic anemia; (5) Multiorgan transplantation; (6) Complicated with tumor; (7) Complicated with connective tissue disease; (8) Pregnant patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • No. 17, Lujiang Road, Luyang District, Hefei City, Anhui Province, China — Хэфэй

Идентификаторы

NCT: NCT07231770 · USTC-PJP-Pro · 2023-ky041

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗