The azithromycin to prevent wheezing following severe RSV bronchiolitis-II clinical trial: Rationale, study design, methods, and characteristics of study population.
The azithromycin to prevent wheezing following severe RSV bronchiolitis-II clinical trial: Rationale, study design, methods, and characteristics of study population.
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阿奇霉素预防严重RSV细支气管炎后喘息-II临床试验：原理、研究设计、方法和研究人群特征。
DOI：
10.1016/j.conctc.2021.100798
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发表时间：
2021-06
影响因子：
1.5
通讯作者：
Beigelman A
中科院分区：
文献类型：
--
作者：
Srinivasan M;Bacharier LB;Goss CW;Zhou Y;Boomer J;Bram S;Burgdorf D;Burnham CA;Casper T;Castro M;Coverstone A;Haslam M;Kanchongkittiphon W;Kuklinski C;Lian Q;Schechtman K;Storch GA;True K;Wallace MA;Yin-DeClue H;Ahrens E;Wang J;Beigelman A
严重呼吸道合胞病毒(RSV)毛细支气管炎是未来反复喘息和哮喘的重要危险因素。阿奇霉素预防重症呼吸道合胞病毒毛细支气管炎II期(APW-RSV II)后喘息的临床试验的目标是评估阿奇霉素治疗患有呼吸道合胞病毒毛细支气管炎的婴儿是否减少学龄前阶段呼吸道合胞病毒毛细支气管炎的发生。APW-RSV II临床试验是一项双盲、安慰剂对照、平行组、随机试验，包括因RSV毛细支气管炎住院的其他健康参与者，年龄30天-18个月。这项研究包括用阿奇霉素或安慰剂进行为期2周的积极随机治疗阶段，以及为期18-48个月的观察期。从2016年秋季开始，200名参与者在连续三个RSV季节招募，随机接受口服阿奇霉素10 mg/kg/d，连续7天，然后再服用5 mg/kg/d，或匹配的安慰剂。研究假设是，在呼吸道合胞病毒毛细支气管炎住院的婴儿中，在常规毛细支气管炎护理的基础上加用阿奇霉素治疗将减少呼吸道合胞病毒感染后复发喘息(≥3次发作)的可能性。主要的临床结果是出现第三次喘息，每隔一个月通过电话问卷和每年的面对面访问进行评估。APW-RSV II临床试验的第二个目标是检查阿奇霉素治疗如何改变上呼吸道微生物群组成，并确定这些变化是否与RSV后RW的发生有关。在研究治疗前后获得的鼻腔冲洗样本中的微生物组组成进行了表征。这项临床试验可能确定在严重的呼吸道合胞病毒毛细支气管炎期间应用第一种有效的干预措施，以降低呼吸道合胞病毒感染后RW和最终哮喘的风险。
Severe respiratory syncytial virus (RSV) bronchiolitis in early life is a significant risk factor for future recurrent wheeze (RW) and asthma. The goal of the Azithromycin to Prevent Wheezing following severe RSV bronchiolitis II (APW-RSV II) clinical trial is to evaluate if azithromycin treatment in infants hospitalized with RSV bronchiolitis reduces the occurrence of RW during the preschool years. The APW-RSV II clinical trial is a double-blind, placebo-controlled, parallel-group, randomized trial, including otherwise healthy participants, ages 30 days-18 months, who are hospitalized due to RSV bronchiolitis. The study includes an active randomized treatment phase with azithromycin or placebo for 2 weeks, and an observational phase of 18–48 months. Two hundred participants were enrolled during three consecutive RSV seasons beginning in the fall of 2016 and were randomized to receive oral azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for an additional 7 days, or matched placebo. The study hypothesis is that in infants hospitalized with RSV bronchiolitis, the addition of azithromycin therapy to routine bronchiolitis care would reduce the likelihood of developing post-RSV recurrent wheeze (≥3 episodes). The primary clinical outcome is the occurrence of a third episode of wheezing, which is evaluated every other month by phone questionnaires and during yearly in-person visits. A secondary objective of the APW-RSV II clinical trial is to examine how azithromycin therapy changes the upper airway microbiome composition, and to determine if these changes are related to the occurrence of post-RSV RW. Microbiome composition is characterized in nasal wash samples obtained before and after the study treatments. This clinical trial may identify the first effective intervention applied during severe RSV bronchiolitis to reduce the risk of post-RSV RW and ultimately asthma.
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随机试验评估阿奇霉素对血清和上呼吸道IL-8水平的影响，并在患有呼吸道合胞病毒细支气管炎的婴儿中复发。
DOI：
10.1016/j.jaci.2014.10.001
发表时间：
2015-05
期刊：
The Journal of allergy and clinical immunology
影响因子：
--
作者：
Beigelman A;Isaacson-Schmid M;Sajol G;Baty J;Rodriguez OM;Leege E;Lyons K;Schweiger TL;Zheng J;Schechtman KB;Castro M;Bacharier LB
通讯作者：
Bacharier LB
影响因子：
158.5
作者：
Bisgaard, Hans;Hermansen, Mette Northman;Pipper, Christian Bressen
通讯作者：
Pipper, Christian Bressen
影响因子：
8
作者：
Akinbami, Lara J.;Moorman, Jeanne E.;Sondik, Edward J.
通讯作者：
Sondik, Edward J.
DOI：
10.1001/jama.2015.13896
发表时间：
2015-11-17
期刊：
JAMA
影响因子：
--
作者：
Bacharier LB;Guilbert TW;Mauger DT;Boehmer S;Beigelman A;Fitzpatrick AM;Jackson DJ;Baxi SN;Benson M;Burnham CD;Cabana M;Castro M;Chmiel JF;Covar R;Daines M;Gaffin JM;Gentile DA;Holguin F;Israel E;Kelly HW;Lazarus SC;Lemanske RF Jr;Ly N;Meade K;Morgan W;Moy J;Olin T;Peters SP;Phipatanakul W;Pongracic JA;Raissy HH;Ross K;Sheehan WJ;Sorkness C;Szefler SJ;Teague WG;Thyne S;Martinez FD
通讯作者：
Martinez FD
影响因子：
4.6
作者：
Chen IL;Huang HC;Chang YH;Huang HY;Yeh WJ;Wu TY;Suen JL;Yang SN;Hung CH
通讯作者：
Hung CH