How long to take sulfamethoxazole after a kidney transplant
A Controlled Study on the Prophylaxis of Pneumocystis Jirovecii Pneumonia With Fixed-dose Compound Sulfamethoxazole Tablets of Different Maintenance Durations After Renal Transplantation
This study will test whether different lengths of sulfamethoxazole (TMP‑SMX) taken after a kidney transplant better prevent Pneumocystis jirovecii pneumonia in adult transplant recipients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07231770 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adult kidney transplant recipients who will receive time-driven sulfamethoxazole (TMP‑SMX) prophylaxis according to predefined dosing schedules to compare infection outcomes. Participants will be followed clinically with testing for PJP using sputum GMS stain, direct immunofluorescence or PCR on induced sputum or BALF, and metagenomic next‑generation sequencing when indicated. The design targets the observed pattern of PJP incidence, which shows a peak around 9 months and a second peak between 10 and 15 months after transplantation. The goal is to clarify an optimal prophylaxis duration where current guideline recommendations and clinical practice vary.
Who should consider this trial
Good fit: Adults aged 18–70 who have received a kidney transplant, are HIV‑negative, have no known TMP‑SMX allergy, and can provide informed consent are ideal candidates.
Not a fit: People who are HIV‑positive, have a history of TMP‑SMX allergy, are outside the 18–70 age range, or cannot comply with follow‑up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could define an optimal TMP‑SMX prevention period that reduces PJP cases while avoiding unnecessary prolonged antibiotic use.
How similar studies have performed: Previous studies have reported PJP occurring more than one year post‑transplant and have used varying prophylaxis durations, so the optimal course remains unsettled.
Eligibility criteria
Show full inclusion / exclusion criteria
Diagnostic Criteria for PJP (meeting one of the following criteria is sufficient): 1. Detection of Pneumocystis jirovecii via sputum Gomori methenamine silver (GMS) stain. 2. According to guidelines/consensus: Positive direct immunofluorescence assay and/or positive polymerase chain reaction (PCR) assay on induced sputum or bronchoalveolar lavage fluid (BALF) specimens. 3. Detection of Pneumocystis jirovecii strains in sputum, blood, or bronchoalveolar lavage fluid (BALF) by metagenomic next-generation sequencing (mNGS). Inclusion Criteria: * Subjects must meet all the following conditions to be enrolled: (1) Age: 18-70 years old; (2) Post-renal transplantation; (3) Voluntarily participate in this clinical study, be able to cooperate with researchers to conduct the study, and sign the informed consent form. Exclusion Criteria: * Criteria: Subjects with any of the following conditions shall be excluded from the trial: (1) HIV-positive; (2) History of TMP-SMX allergy; (3) Glucose-6-phosphate dehydrogenase (G6PD) deficiency; (4) Megaloblastic anemia; (5) Multiorgan transplantation; (6) Complicated with tumor; (7) Complicated with connective tissue disease; (8) Pregnant patients.
Where this trial is running
Hefei, Anhui
- No. 17, Lujiang Road, Luyang District, Hefei City, Anhui Province, China — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Xuqin Jiang
- Email: xqjiang@ustc.edu.cn
- Phone: 13675605989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.