About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Trimethoprim-Sulfamethoxazole (TMP-SMX)
Drug80/400 mg orally once daily for 12 consecutive months for the prophylaxis
Trimethoprim-Sulfamethoxazole (TMP-SMX)
Drug40/200 mg orally once daily for 12 consecutive months for the prophylaxis
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Pneumocystis jiroveciipneumonia (PJP) during the 12-month prophylaxis period after kidney transplantation
The frequency of newly diagnosed Pneumocystis jiroveciipneumonia (PJP) cases occurring within 12 months after kidney transplantation in each group. Diagnosis is confirmed by clinical symptoms, radiological evidence, and microbiological detection (e.g., PCR or staining).
Secondary outcomes
Incidence of TMP-SMX related adverse events during prophylaxis
Frequency of adverse events (AEs) associated with trimethoprim-sulfamethoxazole (TMP-SMX) during the 12-month prophylaxis period. AEs include but are not limited to rash, gastrointestinal intolerance, hematologic abnormalities (e.g., leukopenia), and hepatorenal dysfunction.
Incidence of PJP during the 1-year follow-up after prophylaxis
Frequency of PJP cases, with PJP onset defined as the date of obtaining microbiological evidence, during the 12-month period following completion of prophylaxis.
Incidence of other post-transplant complications
Frequency of other clinically significant complications occurring within 12 months post-transplant, including: Other infections (excluding PJP): bacterial, viral (e.g., CMV, BK virus), fungal, urinary tract, and gastrointestinal infections. Acute rejection episodes. New-onset hypertension or diabetes mellitus.
Clinical prognosis of patients diagnosed with PJP
Clinical outcomes among participants who develop PJP, including: Rate of invasive mechanical ventilation (intubation). Rate of ICU admission. All-cause mortality. Graft survival rate.
Locations
Sponsors and contacts
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Anhui Provincial Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
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