An interventional study of Time-driven dosing in Fever and Chest Tightness, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Anhui Provincial Hospital · Not applicable, Interventional, and Prevention
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 450 is above the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Anhui Provincial Hospital is the lead sponsor of 135 studies on the registry; 101 are open to participants now.
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Diagnostic Criteria for PJP (meeting one of the following criteria is sufficient):
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6-month SMZ prophylaxis
Other: Time-driven dosing
12-month SMZ prophylaxis
Other: Time-driven dosing
18-month SMZ prophylaxis
Other: 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.
Incidence of PJP
Time frame: 18 months after the end of treatment
adverse reaction rate
Time frame: 18 month
Plan to share: No
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