Sung-Han Kim1, Sang-Oh Lee2, In-Ah Park1, Sun-Mi Kim1, Su Jin Park1, Sung-Cheol Yun3, Joo Hee Jung4, Sung Shin4, Young Hoon Kim4, Sang-Ho Choi1, Yang Soo Kim1, Jun Hee Woo1, Su-Kil Park5, Jung Sik Park5, Duck Jong Han4. 1. Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 2. Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea soleemd@amc.seoul.kr. 3. Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 4. Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 5. Department of Nephrology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
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.
RCT Entities:
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: Timothy R Sterling; Gibril Njie; Dominik Zenner; David L Cohn; Randall Reves; Amina Ahmed; Dick Menzies; C Robert Horsburgh; Charles M Crane; Marcos Burgos; Philip LoBue; Carla A Winston; Robert Belknap Journal: MMWR Recomm Rep Date: 2020-02-14
Authors: Omid Rezahosseini; Dina Leth Møller; Andreas Dehlbæk Knudsen; Søren Schwartz Sørensen; Michael Perch; Finn Gustafsson; Allan Rasmussen; Sisse Rye Ostrowski; Susanne Dam Nielsen Journal: Front Immunol Date: 2020-10-15 Impact factor: 7.561