背景:小儿社区获得性肺炎(CAP)可导致长期呼吸道后遗症,包括支气管扩张.我们确定了延长(13-14天)与标准(5-6天)抗生素疗程是否可以改善慢性呼吸道疾病高危人群中CAP住院儿童的长期结局。
方法:我们进行了多中心,双盲,优越性,涉及7名澳大利亚人的随机对照试验,新西兰,马来西亚医院3个月至≤5岁的儿童因接受1-3天静脉注射抗生素而住院,然后口服阿莫西林克拉维酸3天,随机分为延长疗程(8天口服阿莫西林-克拉维酸)或标准疗程(8天口服安慰剂)组.儿童在12个月和24个月时接受检查。主要结局为出院后24个月出现慢性呼吸道症状/体征复合终点(12个月和24个月时出现慢性咳嗽;24个月后出现≥1次急性下呼吸道感染住院;或12个月时出现持续性和/或新的胸部X线征象)的儿童。通过意向治疗分析,其中未完成随访的儿童被认为有慢性呼吸道症状/体征(“最坏情况”)。
结果:总共324名儿童被随机分配[延长疗程(n=163),标准课程(n=161)]。对于我们的主要结果,在扩展课程和标准课程中,97/163(60%)和94/161(58%)儿童出现了慢性呼吸道症状/体征,分别[相对风险(RR)=1.02,95%置信区间(CI):0.85-1.22]。在已知所有亚复合结局的儿童中,组间慢性呼吸道症状/体征,RR=1.10,95%CI:0.69-1.76[延长疗程=27/93(29%),标准疗程=24/91(26%)]。其他敏感性分析也没有显示组间差异。
结论:在因CAP住院的高危人群中,13-14天的抗生素(与5-6天相比),没有改善长期呼吸结局。
BACKGROUND: Pediatric community-acquired pneumonia (CAP) can lead to long-term respiratory sequelae, including bronchiectasis. We determined if an extended (13-14 days) versus standard (5-6 days) antibiotic course improves long-term outcomes in children hospitalized with CAP from populations at high risk of chronic respiratory disease.
METHODS: We undertook a multicenter, double-blind, superiority, randomized controlled trial involving 7 Australian, New Zealand, and Malaysian hospitals. Children aged 3 months to ≤5 years hospitalized with radiographic-confirmed CAP who received 1-3 days of intravenous antibiotics, then 3 days of oral amoxicillin-clavulanate, were randomized to either extended-course (8-day oral amoxicillin-clavulanate) or standard-course (8-day oral placebo) arms. Children were reviewed at 12 and 24 months. The primary outcome was children with the composite endpoint of chronic respiratory symptoms/signs (chronic cough at 12 and 24 months; ≥1 subsequent hospitalized acute lower respiratory infection by 24 months; or persistent and/or new chest radiographic signs at 12-months) at 24-months postdischarge, analyzed by intention-to-treat, where children with incomplete follow-up were assumed to have chronic respiratory symptoms/signs (\"worst-case\" scenario).
RESULTS: A total of 324 children were randomized [extended-course (n = 163), standard-course (n = 161)]. For our primary outcome, chronic respiratory symptoms/signs occurred in 97/163 (60%) and 94/161 (58%) children in the extended-courses and standard-courses, respectively [relative risk (RR) = 1.02, 95% confidence interval (CI): 0.85-1.22]. Among children where all sub-composite outcomes were known, chronic respiratory symptoms/signs between groups, RR = 1.10, 95% CI: 0.69-1.76 [extended-course = 27/93 (29%) and standard-course = 24/91 (26%)]. Additional sensitivity analyses also revealed no between-group differences.
CONCLUSIONS: Among children from high-risk populations hospitalized with CAP, 13-14 days of antibiotics (versus 5-6 days), did not improve long-term respiratory outcomes.