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预防性抗生素以预防神经障碍儿童的胸部感染:帕罗特RCT
Paul S McNamara1, Ashley Paul Jones2, Anne Chang3,4
1Department of Child Health (University of Liverpool), Institute in the Park, Alder Hey Children's Hospital, Liverpool, UK.
Health technology assessment (Winchester, England)
|March 9, 2026
概括
帕罗特试验研究了阿齐思罗米用于预防神经功能障碍儿童下呼吸道感染,但被提前停止. 由于功率不足,它无法确定阿齐思罗米.
科学领域:
- 儿科肺病学 儿科肺病学
- 临床试验 临床试验
- 传染性疾病 传染性疾病
背景情况:
- 患有神经功能障碍的儿童面临高风险的呼吸道疾病和频繁的下呼吸道感染.
- 预防性抗生素的使用正在增加,但对儿科患者有效性的证据有限.
- 帕罗特试验的目的是评估阿齐思罗米在预防这个脆弱群体下呼吸道感染方面的有效性.
研究的目的:
- 评估52周的阿齐思罗米辛预防与安慰剂在减少神经功能障碍儿童下呼吸道感染住院治疗的有效性.
- 提供关于预防性抗生素在儿科神经功能障碍的最佳使用的证据.
主要方法:
- 一个多中心,随机,双盲,安慰剂对照试验 (PARROT) 涉及90名3至17岁的神经障碍和呼吸系统症状的儿童.
- 参与者接受了52周的阿齐思罗米或安慰剂.
- 主要结局是52周期间患上下呼吸道感染住院儿童的比例.
主要成果:
- 由于COVID-19大流行,该试验被提前停止,导致样本大小小小于计划 (n=90).
- 由于下呼吸道感染而住院的病例率在阿齐思罗米辛组为36.7%,在安慰剂组为25.7%.
- 由于早期终止和样本规模较小,该研究没有足够的力量来得出关于阿齐思罗米有效性的最终结论.
结论:
- 由于早期关闭和不足,PARROT试验无法确定阿齐思罗米预防的有效性,以预防神经功能障碍儿童因下呼吸道感染住院治疗的情况.
- 住院患病率是这群人群未来试验的相关主要结果.
- 尽量减少家庭的试验负担对于未来在这个群体中的研究至关重要.
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