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临床试验/ISRCTN79914298
ISRCTN79914298已完成4 期

Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care (ARTIC PC)

niversity of Southampton (UK)0 个研究点目标入组 438 人开始时间: 2015年8月21日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
438

研究概览

简要总结

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34562391/ (added 27/09/2021) 2023 Results article in https://doi.org/10.3310/dgbv3199 (added 13/07/2023)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Children between 6 months and 12 years old presenting with an acute lower respiratory infection (LRTI), defined as an acute cough as the predominant symptom, judged by the GP to be infective in origin, lasting <21 days, and with other symptoms or signs localising to the lower tract (shortness of breath, sputum, pain)
  • Added 26/07/2016:
  • Individuals who are allergic to penicillin, who cannot be randomised (e.g. with known immune deficiency, or where a complication such as pneumonia is suspected on clinical grounds), or are unwilling to be randomised, are still eligible for the observational study where the same outcomes will be measured.

排除标准

  • 1. The cough is judged by the clinician to have a non-infectious aetiology (e.g., hayfever or non-infective exacerbation of asthma) or almost certain viral aetiology (croup, where antibiotics are not commonly prescribed)
  • 2. Immune-compromised
  • 3. Antibiotic use in previous 30 days
  • 4. For the trial, suspected pneumonia based on clinical examination or being very severely ill as judged by the GP is an exclusion (but such children can still enter the observational study which will allow for an assessment of trial participants’ external validity)
  • 5. Only one child from each household will be recruited

研究者

发起方
niversity of Southampton (UK)

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