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Sulfamethoxazole Prophylaxis Duration After Renal Transplantation

RecruitingNAAges 18 Years - anyAllAnhui Provincial Hospital
NCT07231770 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Diagnostic Criteria for PJP (meeting one of the following criteria is sufficient): 1. Detection of Pneumocystis jirovecii via sputum Gomori methenamine silver (GMS) stain. 2. 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. 3. Detection of Pneumocystis jirovecii strains in sputum, blood, or bronchoalveolar lavage fluid (BALF) by metagenomic next-generation sequencing (mNGS). Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Time-driven dosing
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Where

1 site
No. 17, Lujiang Road, Luyang District, Hefei City, Anhui Province, China
Hefei, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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