Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation

Официальное название

A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation

Обзор

This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients. Participants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications. Participants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.

Подробное описание

Pneumocystis jirovecii pneumonia (PJP) remains a significant opportunistic infection in kidney transplant recipients and continues to pose a major clinical challenge. Although trimethoprim-sulfamethoxazole (TMP-SMX) is widely used for prophylaxis, its tolerability is often limited by adverse effects, which may compromise adherence during long-term use. Therefore, identifying an optimal dosing strategy that maintains efficacy while improving safety is of considerable clinical importance.

This multicenter, prospective, randomized controlled trial is designed to compare the efficacy and safety of low-dose versus standard-dose TMP-SMX for PJP prophylaxis after kidney transplantation. Adult kidney transplant recipients with stable renal function after transplantation will be enrolled and randomly assigned in a 1:1 ratio to receive either a low-dose or standard-dose TMP-SMX regimen for 12 months following transplantation.

The primary outcome is the incidence of PJP during the 12-month prophylaxis period. Secondary outcomes include treatment-related adverse events, rates of dose modification or discontinuation, and the occurrence and timing of PJP after cessation of prophylaxis, as well as other post-transplant clinical outcomes. All participants will be followed for a total of 24 months, including a 12-month treatment period and an additional follow-up period after discontinuation. The results of this study are expected to provide evidence to inform optimal prophylactic strategies for PJP in kidney transplant recipients, with the aim of improving both efficacy and safety in clinical practice.

Вмешательства

• Препарат Trimethoprim-Sulfamethoxazole (TMP-SMX)
  80/400 mg orally once daily for 12 consecutive months for the prophylaxis
• Препарат Trimethoprim-Sulfamethoxazole (TMP-SMX)
  40/200 mg orally once daily for 12 consecutive months for the prophylaxis

Первичные конечные точки

• Incidence of Pneumocystis jiroveciipneumonia (PJP) during the 12-month prophylaxis period after kidney transplantation [Срок оценки: 12 months post-kidney transplantation]

Вторичные конечные точки (4)

• Incidence of TMP-SMX related adverse events during prophylaxis [Срок оценки: 12 months post-kidney transplantation]
• Incidence of PJP during the 1-year follow-up after prophylaxis [Срок оценки: 12 to 24 months post-kidney transplantation]
• Incidence of other post-transplant complications [Срок оценки: 12 months post-kidney transplantation]
• Clinical prognosis of patients diagnosed with PJP [Срок оценки: 24 months post-kidney transplantation]

Критерии участия

Критерии включения

-Age: Between 18 and 70 years old. Transplant Status: Recipients of a first-time kidney transplant. Renal Function: Serum creatinine levels have stabilized with a creatinine -----clearance (CrCl) > 30 mL/min.

Consent \& Compliance: Voluntarily agree to participate in this study, are capable of cooperating with the investigators, and have signed the informed consent form.

Критерии исключения

-HIV Infection: Known HIV positive status. Drug Allergy: History of allergy or hypersensitivity to TMP-SMX (Trimethoprim-Sulfamethoxazole).

Prior PJP: History of Pneumocystis jirovecii pneumonia (PJP) before transplantation.

G6PD Deficiency: Glucose-6-phosphate dehydrogenase deficiency. Multi-organ Transplant: Recipients of multi-organ transplants. Active Infection: Presence of other severe concurrent infections. Immune System Disorders: Concomitant diseases affecting the immune system (e.g., malignancies/tumors, connective tissue diseases, hematological system diseases).

Pregnancy: Pregnant women. Anemia: Megaloblastic anemia. Non-compliance: Inability to adhere to regular follow-up schedules or poor compliance.

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

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07619027 · 2025KY938

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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