Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation (TMP-SMX PJP)
A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Pneumocystis jirovecii pneumonia (PJP) remains a significant opportunistic infection in kidney transplant recipients and continues to pose a major clinical challenge. Although trimethoprim-sulfamethoxazole (TMP-SMX) is widely used for prophylaxis, its tolerability is often limited by adverse effects, which may compromise adherence during long-term use. Therefore, identifying an optimal dosing strategy that maintains efficacy while improving safety is of considerable clinical importance.
This multicenter, prospective, randomized controlled trial is designed to compare the efficacy and safety of low-dose versus standard-dose TMP-SMX for PJP prophylaxis after kidney transplantation. Adult kidney transplant recipients with stable renal function after transplantation will be enrolled and randomly assigned in a 1:1 ratio to receive either a low-dose or standard-dose TMP-SMX regimen for 12 months following transplantation.
The primary outcome is the incidence of PJP during the 12-month prophylaxis period. Secondary outcomes include treatment-related adverse events, rates of dose modification or discontinuation, and the occurrence and timing of PJP after cessation of prophylaxis, as well as other post-transplant clinical outcomes. All participants will be followed for a total of 24 months, including a 12-month treatment period and an additional follow-up period after discontinuation. The results of this study are expected to provide evidence to inform optimal prophylactic strategies for PJP in kidney transplant recipients, with the aim of improving both efficacy and safety in clinical practice.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Xuqin jiang
- Numero di telefono: +86-13675605989
- Email: xqjiang@ustc.edu.cn
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
-Age: Between 18 and 70 years old. Transplant Status: Recipients of a first-time kidney transplant. Renal Function: Serum creatinine levels have stabilized with a creatinine -----clearance (CrCl) > 30 mL/min.
Consent & Compliance: Voluntarily agree to participate in this study, are capable of cooperating with the investigators, and have signed the informed consent form.
Exclusion Criteria:
-HIV Infection: Known HIV positive status. Drug Allergy: History of allergy or hypersensitivity to TMP-SMX (Trimethoprim-Sulfamethoxazole).
Prior PJP: History of Pneumocystis jirovecii pneumonia (PJP) before transplantation.
G6PD Deficiency: Glucose-6-phosphate dehydrogenase deficiency. Multi-organ Transplant: Recipients of multi-organ transplants. Active Infection: Presence of other severe concurrent infections. Immune System Disorders: Concomitant diseases affecting the immune system (e.g., malignancies/tumors, connective tissue diseases, hematological system diseases).
Pregnancy: Pregnant women. Anemia: Megaloblastic anemia. Non-compliance: Inability to adhere to regular follow-up schedules or poor compliance.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Standard Dose Group
Participants receive standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) 80/400 mg once daily for 12 consecutive months for the prevention of Pneumocystis jirovecii pneumonia (PJP) after kidney transplantation.
|
80/400 mg orally once daily for 12 consecutive months for the prophylaxis
40/200 mg orally once daily for 12 consecutive months for the prophylaxis
|
|
Sperimentale: Low Dose Group
Participants receive trimethoprim-sulfamethoxazole (TMP-SMX) 40/200 mg (half tablet) once daily for 12 consecutive months for the prevention of Pneumocystis jirovecii pneumonia (PJP) after kidney transplantation.
|
80/400 mg orally once daily for 12 consecutive months for the prophylaxis
40/200 mg orally once daily for 12 consecutive months for the prophylaxis
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Pneumocystis jiroveciipneumonia (PJP) during the 12-month prophylaxis period after kidney transplantation
Lasso di tempo: 12 months post-kidney transplantation
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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).
|
12 months post-kidney transplantation
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of TMP-SMX related adverse events during prophylaxis
Lasso di tempo: 12 months post-kidney transplantation
|
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.
|
12 months post-kidney transplantation
|
|
Incidence of PJP during the 1-year follow-up after prophylaxis
Lasso di tempo: 12 to 24 months post-kidney transplantation
|
Frequency of PJP cases, with PJP onset defined as the date of obtaining microbiological evidence, during the 12-month period following completion of prophylaxis.
|
12 to 24 months post-kidney transplantation
|
|
Incidence of other post-transplant complications
Lasso di tempo: 12 months post-kidney transplantation
|
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. |
12 months post-kidney transplantation
|
|
Clinical prognosis of patients diagnosed with PJP
Lasso di tempo: 24 months post-kidney transplantation
|
Clinical outcomes among participants who develop PJP, including: Rate of invasive mechanical ventilation (intubation). Rate of ICU admission. All-cause mortality. Graft survival rate. |
24 months post-kidney transplantation
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni delle vie respiratorie
- Infezioni
- Malattie delle vie respiratorie
- Malattie polmonari
- Polmonite
- Infezioni batteriche e micosi
- Malattie polmonari, fungine
- Infezioni da Pneumocystis
- Micosi
- Polmonite, Pneumocystis
- Composti di zolfo
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Preparati farmaceutici
- Idrocarburi
- Idrocarburi, ciclici
- Idrocarburi, aromatici
- Amides
- Composti di anilina
- Ammine
- Pirimidine
- Derivati di benzene
- Combinazioni di droga
- Sulfametossazolo
- Benzenesulfonamides
- Sulfonamidi
- Sulfanilamides
- Solfoni
- Trimetoprim
- Combinazione di farmaci trimetoprim e sulfametossazolo
Altri numeri di identificazione dello studio
- 2025KY938
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Informazioni su farmaci e dispositivi, documenti di studio
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