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NOT YET RECRUITING
NCT07619027
PHASE4

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

Sponsor: Anhui Provincial Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1084

Start Date

2026-06

Completion Date

2030-06

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Trimethoprim-Sulfamethoxazole (TMP-SMX)

80/400 mg orally once daily for 12 consecutive months for the prophylaxis

DRUG

Trimethoprim-Sulfamethoxazole (TMP-SMX)

40/200 mg orally once daily for 12 consecutive months for the prophylaxis