Clinical trial Recruiting at 1 site Interventional Ages 18 and up

How long to take sulfamethoxazole after a kidney transplant

Official title: A Controlled Study on the Prophylaxis of Pneumocystis Jirovecii Pneumonia With Fixed-dose Compound Sulfamethoxazole Tablets of Different Maintenance Durations After Renal Transplantation

Run by Anhui Provincial Hospital · NCT07231770 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment450 (estimated)
SponsorAnhui Provincial Hospital
Government
Locations1 site (Hefei, Anhui)
StatusRecruiting
StartedMay 28, 2024
Main results expectedFebruary 28, 2026
Study endsAugust 8, 2027
Registry record updatedDecember 16, 2025
Trial IDNCT07231770 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have reported PJP occurring more than one year post‑transplant and have used varying prophylaxis durations, so the optimal course remains unsettled.

Who can join: the full rules

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 it's running

  • No. 17, Lujiang Road, Luyang District, Hefei City, Anhui Province, China
    Hefei, Anhui, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.