PDF(Pubmed)
Abstract：
Short influenza postexposure prophylaxis (PEP) showed high efficacy in adults, but studies in children are lacking. This randomized open-label pilot trial aimed to verify noninferiority of a 3- versus 7-day prophylaxis with oral oseltamivir in hospitalized children. Influenza contacts were randomized to the 3- or 7-day group and efficacy, relative risk of adverse events (AEs), and the cumulative costs of drugs and AEs management were compared. The intention-to-treat (ITT) analysis included 59 children (n = 28 and n = 31 in the 3- and 7-day group, respectively). The efficacy was 100% (95% CI 87.7-100%) versus 93.6% (95% CI 78.6-99.2%) in the 3- and 7-day group; the differences were statistically insignificant. A per-protocol (PP) analysis including 56 patients (n = 27 and n = 29, respectively) showed 100% (95% CI 87.2-100%) and 93.1% (95% CI 77.2-99.2%) efficacy, respectively, without statistical significance. Differences were within the predefined noninferiority margin with an efficacy difference Δ = 6.45 percentage points (p.p.) with 1-sided 95% CI (- 2.8, - 1.31, p = 0.86; ITT) and Δ = 6.9 p.p. (1-sided 95% CI - 2.83, - 1.27, p = 0.85; PP). Adverse events did not differ significantly, while the cumulative costs of the prophylaxis and AEs management were higher in the 7-day group (median 10.5 euro vs. 4.5 euro, p < 0.01). This pilot study showed the noninferiority of the 3-day versus 7-day PEP, which was associated with lower costs.Trial registration number: NCT04297462, 5th March 2020, restrospectively registered.
摘要：
短期流感暴露后预防（PEP）在成人中显示出很高的疗效，但是缺乏对儿童的研究。这项随机开放标签试点试验旨在验证住院儿童口服奥司他韦3天与7天预防的非劣效性。流感接触者被随机分配到3天或7天组，不良事件的相对风险（AE），并比较了药物和AE管理的累积成本。意向治疗（ITT）分析包括59名儿童（3天和7天组中n=28和n=31，分别)。3天和7天组的疗效分别为100％（95％CI87.7-100％）和93.6％（95％CI78.6-99.2％）；差异无统计学意义。包括56例患者（分别为27例和29例）的符合方案（PP）分析显示100％（95％CI87.2-100％）和93.1％（95％CI77.2-99.2％）疗效，分别,没有统计学意义。差异在预定义的非劣效性范围内，疗效差异Δ=6.45个百分点（p.p.），单侧95％CI（-2.8，-1.31，p=0.86；ITT）和Δ=6.9p.p.（单侧95％CI-2.83，-1.27，p=0.85；PP）。不良事件没有显著差异，而7天组的预防和不良事件管理的累积成本较高(中位数为10.5欧元vs.4.5欧元,p<0.01)。这项初步研究显示了3天PEP与7天PEP的非劣效性，这与较低的成本有关。试用注册号：NCT04297462，2020年3月5日，重新注册。
