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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAnhui Provincial Hospital

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trimethoprim-Sulfamethoxazole (TMP-SMX)

    Drug

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

  • Trimethoprim-Sulfamethoxazole (TMP-SMX)

    Drug

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

Treatment groups

1,084 Participants
are divided into 2 treatment groups
Group A: Standard Dose GroupActive comparator 1 intervention
Group B: Low Dose GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 months post-kidney transplantation

Secondary outcomes

1

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.

Time frame
12 months post-kidney transplantation
2

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.

Time frame
12 to 24 months post-kidney transplantation
3

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.

Time frame
12 months post-kidney transplantation
4

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.

Time frame
24 months post-kidney transplantation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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