Clarithromycin plus intravenous immunoglobulin therapy can reduce the relapse rate of Kawasaki disease: A phase 2, open-label, randomized control study

Etsuro Nanishi, Hisanori Nishio, Hidetoshi Takada, Kenichiro Yamamura, Mitsuharu Fukazawa, Kenji Furuno, Yumi Mizuno, Kenjiro Saigo, Ryo Kadoya, Noriko Ohbuchi, Yasuhiro Onoe, Hironori Yamashita, Hideki Nakayama, Takuya Hara, Takuro Ohno, Yasuhiko Takahashi, Ken Hatae, Tatsuo Harada, Takayuki Shimose, Junji KishimotoShoichi Ohga, Toshiro Hara

研究成果: ジャーナルへの寄稿記事

1 引用 (Scopus)

抄録

Background-We previously reported that biofilms and innate immunity contribute to the pathogenesis of Kawasaki disease. Therefore, we aimed to assess the efficacy of clarithromycin, an antibiofilm agent, in patients with Kawasaki disease. Methods and Results-We conducted an open-label, multicenter, randomized, phase 2 trial at 8 hospitals in Japan. Eligible patients included children aged between 4 months and 5 years who were enrolled between days 4 and 8 of illness. Participants were randomly allocated to receive either intravenous immunoglobulin (IVIG) or IVIG plus clarithromycin. The primary end point was the duration of fever after the initiation of IVIG treatment. Eighty-one eligible patients were randomized. The duration of the fever did not differ between the 2 groups (mean±SD, 34.3±32.4 and 31.1±31.1 hours in the IVIG plus clarithromycin group and the IVIG group, respectively [P=0.66]). The relapse rate of patients in the IVIG plus clarithromycin group was significantly lower than that in the IVIG group (12.5% versus 30.8%, P=0.046). No serious adverse events occurred during the study period. In a post hoc analysis, the patients in the IVIG plus clarithromycin group required significantly shorter mean lengths of hospital stays than those in the IVIG group (8.9 days versus 10.3 days, P=0.049). Conclusions-Although IVIG plus clarithromycin therapy failed to shorten the duration of fever, it reduced the relapse rate and shortened the duration of hospitalization in patients with Kawasaki disease.

元の言語英語
記事番号e005370
ジャーナルJournal of the American Heart Association
6
発行部数7
DOI
出版物ステータス出版済み - 7 1 2017

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Mucocutaneous Lymph Node Syndrome
Passive Immunization
Clarithromycin
Intravenous Immunoglobulins
Recurrence
Fever
Length of Stay
Proxy
Biofilms
Innate Immunity
Japan
Hospitalization

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

これを引用

Clarithromycin plus intravenous immunoglobulin therapy can reduce the relapse rate of Kawasaki disease : A phase 2, open-label, randomized control study. / Nanishi, Etsuro; Nishio, Hisanori; Takada, Hidetoshi; Yamamura, Kenichiro; Fukazawa, Mitsuharu; Furuno, Kenji; Mizuno, Yumi; Saigo, Kenjiro; Kadoya, Ryo; Ohbuchi, Noriko; Onoe, Yasuhiro; Yamashita, Hironori; Nakayama, Hideki; Hara, Takuya; Ohno, Takuro; Takahashi, Yasuhiko; Hatae, Ken; Harada, Tatsuo; Shimose, Takayuki; Kishimoto, Junji; Ohga, Shoichi; Hara, Toshiro.

:: Journal of the American Heart Association, 巻 6, 番号 7, e005370, 01.07.2017.

研究成果: ジャーナルへの寄稿記事

Nanishi, E, Nishio, H, Takada, H, Yamamura, K, Fukazawa, M, Furuno, K, Mizuno, Y, Saigo, K, Kadoya, R, Ohbuchi, N, Onoe, Y, Yamashita, H, Nakayama, H, Hara, T, Ohno, T, Takahashi, Y, Hatae, K, Harada, T, Shimose, T, Kishimoto, J, Ohga, S & Hara, T 2017, 'Clarithromycin plus intravenous immunoglobulin therapy can reduce the relapse rate of Kawasaki disease: A phase 2, open-label, randomized control study', Journal of the American Heart Association, 巻. 6, 番号 7, e005370. https://doi.org/10.1161/JAHA.116.005370
Nanishi, Etsuro ; Nishio, Hisanori ; Takada, Hidetoshi ; Yamamura, Kenichiro ; Fukazawa, Mitsuharu ; Furuno, Kenji ; Mizuno, Yumi ; Saigo, Kenjiro ; Kadoya, Ryo ; Ohbuchi, Noriko ; Onoe, Yasuhiro ; Yamashita, Hironori ; Nakayama, Hideki ; Hara, Takuya ; Ohno, Takuro ; Takahashi, Yasuhiko ; Hatae, Ken ; Harada, Tatsuo ; Shimose, Takayuki ; Kishimoto, Junji ; Ohga, Shoichi ; Hara, Toshiro. / Clarithromycin plus intravenous immunoglobulin therapy can reduce the relapse rate of Kawasaki disease : A phase 2, open-label, randomized control study. :: Journal of the American Heart Association. 2017 ; 巻 6, 番号 7.
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abstract = "Background-We previously reported that biofilms and innate immunity contribute to the pathogenesis of Kawasaki disease. Therefore, we aimed to assess the efficacy of clarithromycin, an antibiofilm agent, in patients with Kawasaki disease. Methods and Results-We conducted an open-label, multicenter, randomized, phase 2 trial at 8 hospitals in Japan. Eligible patients included children aged between 4 months and 5 years who were enrolled between days 4 and 8 of illness. Participants were randomly allocated to receive either intravenous immunoglobulin (IVIG) or IVIG plus clarithromycin. The primary end point was the duration of fever after the initiation of IVIG treatment. Eighty-one eligible patients were randomized. The duration of the fever did not differ between the 2 groups (mean±SD, 34.3±32.4 and 31.1±31.1 hours in the IVIG plus clarithromycin group and the IVIG group, respectively [P=0.66]). The relapse rate of patients in the IVIG plus clarithromycin group was significantly lower than that in the IVIG group (12.5{\%} versus 30.8{\%}, P=0.046). No serious adverse events occurred during the study period. In a post hoc analysis, the patients in the IVIG plus clarithromycin group required significantly shorter mean lengths of hospital stays than those in the IVIG group (8.9 days versus 10.3 days, P=0.049). Conclusions-Although IVIG plus clarithromycin therapy failed to shorten the duration of fever, it reduced the relapse rate and shortened the duration of hospitalization in patients with Kawasaki disease.",
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T1 - Clarithromycin plus intravenous immunoglobulin therapy can reduce the relapse rate of Kawasaki disease

T2 - A phase 2, open-label, randomized control study

AU - Nanishi, Etsuro

AU - Nishio, Hisanori

AU - Takada, Hidetoshi

AU - Yamamura, Kenichiro

AU - Fukazawa, Mitsuharu

AU - Furuno, Kenji

AU - Mizuno, Yumi

AU - Saigo, Kenjiro

AU - Kadoya, Ryo

AU - Ohbuchi, Noriko

AU - Onoe, Yasuhiro

AU - Yamashita, Hironori

AU - Nakayama, Hideki

AU - Hara, Takuya

AU - Ohno, Takuro

AU - Takahashi, Yasuhiko

AU - Hatae, Ken

AU - Harada, Tatsuo

AU - Shimose, Takayuki

AU - Kishimoto, Junji

AU - Ohga, Shoichi

AU - Hara, Toshiro

PY - 2017/7/1

Y1 - 2017/7/1

N2 - Background-We previously reported that biofilms and innate immunity contribute to the pathogenesis of Kawasaki disease. Therefore, we aimed to assess the efficacy of clarithromycin, an antibiofilm agent, in patients with Kawasaki disease. Methods and Results-We conducted an open-label, multicenter, randomized, phase 2 trial at 8 hospitals in Japan. Eligible patients included children aged between 4 months and 5 years who were enrolled between days 4 and 8 of illness. Participants were randomly allocated to receive either intravenous immunoglobulin (IVIG) or IVIG plus clarithromycin. The primary end point was the duration of fever after the initiation of IVIG treatment. Eighty-one eligible patients were randomized. The duration of the fever did not differ between the 2 groups (mean±SD, 34.3±32.4 and 31.1±31.1 hours in the IVIG plus clarithromycin group and the IVIG group, respectively [P=0.66]). The relapse rate of patients in the IVIG plus clarithromycin group was significantly lower than that in the IVIG group (12.5% versus 30.8%, P=0.046). No serious adverse events occurred during the study period. In a post hoc analysis, the patients in the IVIG plus clarithromycin group required significantly shorter mean lengths of hospital stays than those in the IVIG group (8.9 days versus 10.3 days, P=0.049). Conclusions-Although IVIG plus clarithromycin therapy failed to shorten the duration of fever, it reduced the relapse rate and shortened the duration of hospitalization in patients with Kawasaki disease.

AB - Background-We previously reported that biofilms and innate immunity contribute to the pathogenesis of Kawasaki disease. Therefore, we aimed to assess the efficacy of clarithromycin, an antibiofilm agent, in patients with Kawasaki disease. Methods and Results-We conducted an open-label, multicenter, randomized, phase 2 trial at 8 hospitals in Japan. Eligible patients included children aged between 4 months and 5 years who were enrolled between days 4 and 8 of illness. Participants were randomly allocated to receive either intravenous immunoglobulin (IVIG) or IVIG plus clarithromycin. The primary end point was the duration of fever after the initiation of IVIG treatment. Eighty-one eligible patients were randomized. The duration of the fever did not differ between the 2 groups (mean±SD, 34.3±32.4 and 31.1±31.1 hours in the IVIG plus clarithromycin group and the IVIG group, respectively [P=0.66]). The relapse rate of patients in the IVIG plus clarithromycin group was significantly lower than that in the IVIG group (12.5% versus 30.8%, P=0.046). No serious adverse events occurred during the study period. In a post hoc analysis, the patients in the IVIG plus clarithromycin group required significantly shorter mean lengths of hospital stays than those in the IVIG group (8.9 days versus 10.3 days, P=0.049). Conclusions-Although IVIG plus clarithromycin therapy failed to shorten the duration of fever, it reduced the relapse rate and shortened the duration of hospitalization in patients with Kawasaki disease.

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