Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
PLoS One. 2013 Sep 25;8(9):e74316. doi: 10.1371/journal.pone.0074316. eCollection 2013.
Bronchiolitis, one of the most common reasons for hospitalisation in young children, is particularly problematic in Indigenous children. Macrolides may be beneficial in settings where children have high rates of nasopharyngeal bacterial carriage and frequent prolonged illness. The aim of our double-blind placebo-controlled randomised trial was to determine if a large single dose of azithromycin (compared to placebo) reduced length of stay (LOS), duration of oxygen (O2) and respiratory readmissions within 6 months of children hospitalised with bronchiolitis. We also determined the effect of azithromycin on nasopharyngeal microbiology.
Children aged ≤18 months were randomised to receive a single large dose (30 mg/kg) of either azithromycin or placebo within 24 hrs of hospitalisation. Nasopharyngeal swabs were collected at baseline and 48 hrs later. Primary endpoints (LOS, O2) were monitored every 12 hrs. Hospitalised respiratory readmissions 6-months post discharge was collected.
97 children were randomised (n = 50 azithromycin, n = 47 placebo). Median LOS was similar in both groups; azithromycin = 54 hours, placebo = 58 hours (difference between groups of 4 hours 95%CI -8, 13, p = 0.6). O2 requirement was not significantly different between groups; Azithromycin = 35 hrs; placebo = 42 hrs (difference 7 hours, 95%CI -9, 13, p = 0.7). Number of children re-hospitalised was similar 10 per group (OR = 0.9, 95%CI 0.3, 2, p = 0.8). At least one virus was detected in 74% of children. The azithromycin group had reduced nasopharyngeal bacterial carriage (p = 0.01) but no difference in viral detection at 48 hours.
Although a single dose of azithromycin reduces carriage of bacteria, it is unlikely to be beneficial in reducing LOS, duration of O2 requirement or readmissions in children hospitalised with bronchiolitis. It remains uncertain if an earlier and/or longer duration of azithromycin improves clinical and microbiological outcomes for children. The trial was registered with the Australian and New Zealand Clinical Trials Register. Clinical trials number: ACTRN12608000150347. http://www.anzctr.org.au/TrialSearch.aspx.
毛细支气管炎是导致幼儿住院的最常见原因之一，在原住民儿童中尤其成问题。大环内酯类药物可能对鼻咽部细菌携带率高且经常长时间患病的儿童有益。我们的双盲安慰剂对照随机试验的目的是确定大剂量单次阿奇霉素（与安慰剂相比）是否可以减少毛细支气管炎患儿住院期间的住院时间（ LOS ）、氧（ O2 ）持续时间和 6 个月内的呼吸再入院率。我们还确定了阿奇霉素对鼻咽微生物的影响。
≤18 个月的儿童在住院后 24 小时内随机接受单次大剂量（ 30mg/kg ）阿奇霉素或安慰剂。在基线和 48 小时后采集鼻咽拭子。每隔 12 小时监测主要终点（ LOS ， O2 ）。收集出院后 6 个月内的住院呼吸再入院情况。
97 名儿童被随机分组（ n ＝ 50 例阿奇霉素， n ＝ 47 例安慰剂）。两组的中位 LOS 相似；阿奇霉素组＝54 小时，安慰剂组＝58 小时（组间差异为 4 小时， 95％CI 为-8 ， 13 ， p ＝0.6 ）。两组的 O2 需求无显著差异；阿奇霉素组＝35 小时；安慰剂组＝42 小时（差异 7 小时， 95％CI 为-9 ， 13 ， p ＝0.7 ）。每组再住院的儿童人数相似，均为 10 例（ OR ＝0.9 ， 95％CI 为 0.3 ， 2 ， p ＝0.8 ）。74％的儿童至少检测到一种病毒。阿奇霉素组鼻咽细菌携带量减少（ p ＝0.01 ），但 48 小时时病毒检测无差异。
尽管单次剂量的阿奇霉素可减少细菌携带，但不太可能降低毛细支气管炎患儿的 LOS 、 O2 需求持续时间或再入院率。目前尚不确定更早和/或更长时间的阿奇霉素是否能改善儿童的临床和微生物学结局。该试验已在澳大利亚和新西兰临床试验注册中心注册。临床试验编号：ACTRN12608000150347。http://www.anzctr.org.au/TrialSearch.aspx。
