The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Organ transplant recipients are a high incidence group of tuberculosis infection, and the
incidence rate is 7-27 times that of the general population. The prevention of postoperative
tuberculosis infection is an important part of kidney transplant recipients postoperative
follow-up. Taking reasonable tuberculosis prevention strategies for organ transplant
recipients can better prevent the occurrence of postoperative tuberculosis and reduce the
unreasonable use of anti-tuberculosis drugs. The previous screening methods for active
tuberculosis mainly include sputum smear culture, tissue biopsy, tuberculin skin test,
tuberculosis antibody, tuberculosis DNA, and chest imaging. However, there is still a lack of
accurate and effective means for screening for latent tuberculosis infection. The
tuberculosis interferon-γ release test has recently received more and more attention as a
means of screening for potential tuberculosis infection. However, how to apply tuberculosis
interferon-γ release test in clinical practice is still controversial. The investigators hope
to explore the clinical application prospects and practical value of tuberculosis
interferon-γ release test through this research.
According to the conclusion of the retrospective study, the investigators found that the
recipients with negative TSPOT result maybe don't need follow the isoniazid treatment to
prevent the development of tuberculosis even though participants have clinical risk factor of
tuberculosis(include past tuberculosis history, the close contact with active tuberculosis
patients, an area with a high incidence of tuberculosis, abnormal chest x ray performance ).
The investigators will divided the recipients with tuberculosis risk factors into three
groups randomly. Of course, the invention require written informed consent. The first group
with positive tuberculosis interferon gamma release assay (TSPOT) result will follow through
with the treatment ,which is a daily dose of isoniazid for six months(300mg daily) after
kidney transplant surgery. The second group with negative TSPOT result will not follow
through the isoniazid treatment. The third group will follow through with the isoniazid
treatment no matter their TSPOT results. The investigators will conduct a prospective
clinical trial with the first aim of exploring the effectiveness of TSPOT results in kidney
transplant recipients with clinical tuberculosis risk factors, and the second aim of
exploring the benefit of the isoniazid treatment follow the TSPOT results rather than
clinical risk factors.