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 |
| 巻 | 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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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
}
TY - JOUR
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.
UR - http://www.scopus.com/inward/record.url?scp=85025444471&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85025444471&partnerID=8YFLogxK
U2 - 10.1161/JAHA.116.005370
DO - 10.1161/JAHA.116.005370
M3 - Article
C2 - 28684643
AN - SCOPUS:85025444471
VL - 6
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
SN - 2047-9980
IS - 7
M1 - e005370
ER -