title: Isoniazid treatment to prevent TB in kidney and pancreas transplant recipients based on an interferon-γ-releasing assay: an exploratory randomized controlled trial.
abstract: BACKGROUND
  We performed a randomized trial of isoniazid treatment based on interferon-γ-releasing assay (IGRA) in kidney transplant (KT) recipients in an intermediate-TB-burden country.
  
  
  METHODS
  All adult patients admitted to a KT institute between June 2010 and May 2013 were enrolled. The IGRA (T-SPOT.TB assay) was performed on all patients, and isoniazid treatment was given to those with clinical risk factors for latent TB infection (LTBI). Patients with positive IGRA who had no clinical risk factors for LTBI were randomly assigned to isoniazid treatment or a control group. The development of TB after KT was monitored between June 2010 and November 2013. The primary endpoint was the development of TB.
  
  
  RESULTS
  Of the 784 patients who had no clinical risk factors for LTBI, 445 (57%) gave negative results in the IGRA, 76 (10%) indeterminate results and 263 (33%) positive results. Of the latter, 131 were allocated to isoniazid treatment and 132 to the control group. Three (2%) of the control group developed TB, whereas none of the isoniazid treatment group developed TB (rate difference 1.22 per 100 person-years, P = 0.09). Of the 521 patients with negative or indeterminate IGRA results, 4 [0.8%, 0.43 per 100 person-years (95% CI 0.12-1.09)] developed TB after KT.
  
  
  CONCLUSIONS
  IGRA-based isoniazid treatment has a trend towards reducing TB development in KT recipients without clinical risk factors, but careful monitoring of TB development is needed in negative-IGRA KT recipients.
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sung-Han
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea soleemd@amc.seoul.kr.
authors.forename: Sang-Oh
authors.initials: SO
authors.lastname: Lee
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: In-Ah
authors.initials: IA
authors.lastname: Park
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sun-Mi
authors.initials: SM
authors.lastname: Kim
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Su Jin
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sung-Cheol
authors.initials: SC
authors.lastname: Yun
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Joo Hee
authors.initials: JH
authors.lastname: Jung
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sung
authors.initials: S
authors.lastname: Shin
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Young Hoon
authors.initials: YH
authors.lastname: Kim
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sang-Ho
authors.initials: SH
authors.lastname: Choi
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Yang Soo
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Jun Hee
authors.initials: JH
authors.lastname: Woo
authors.affiliation: Department of Nephrology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Su-Kil
authors.initials: SK
authors.lastname: Park
authors.affiliation: Department of Nephrology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Jung Sik
authors.initials: JS
authors.lastname: Park
authors.affiliation: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Duck Jong
authors.initials: DJ
authors.lastname: Han
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D016867:Immunocompromised Host; D015994:Incidence; D059425:Interferon-gamma Release Tests; D007538:Isoniazid / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D016035:Pancreas Transplantation; D066027:Transplant Recipients; D016896:Treatment Outcome; D014376:Tuberculosis / Q000517:prevention & control*
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid
keywords: T-SPOT.TB; TB; kidney transplantation