ISRCTN11369832已完成未知
Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection
niversity of Liverpool0 个研究点目标入组 1,951 人开始时间: 2017年9月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,951
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35078830/ (added 27/01/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 07/11/2019:
- •1. All children aged between 72 hours old and up to 18 years old admitted to hospital for confirmed or suspected SBI, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for more than 48 hours
- •2. Conditions include (but not limited to): bacteraemia, central line-associated bloodstream infections (CLABSIs), uncomplicated bone and joint infections (such as single site infection, osteomyelitis with adjacent septic arthritis or septic arthritis with adjacent osteomyelitis), discitis, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture-negative meningitis, intra-abdominal infections, lymphadenitis, cellulitis
- •3. First time in the BATCH trial
- •Previous inclusion criteria from 02/05/2018 to 07/11/2019:
- •1. All children up to 18 years old admitted to hospital for confirmed or suspected bacterial infection or sepsis, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for at least 48 hours
- •2. Conditions include: bacteraemia, bone and joint infections, discitis, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture-negative meningitis, intra-abdominal infections, lymphadenitis, cellulitis, central line-associated bloodstream infections (CLABSIs) and bacterial endocarditis
- •3. First time in the BATCH trial
- •Original inclusion criteria:
- •1. All children up to 18 years old admitted to hospital for confirmed or suspected bacterial infection or sepsis, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for at least 48 hours
- •2. Conditions include: bacteraemia, bone and joint infections, discitis, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture-negative meningitis, intra-abdominal infections, lymphadenitis, cellulitis, bacterial endocarditis
排除标准
- •Current exclusion criteria as of 07/11/2019:
- •1. Preterm infant age
- •2. Children admitted moribund and not expected to survive more than 24 hours
- •3. Children with a predicted duration of intravenous (IV) antibiotics of less than 48 hours
- •4. Children not expected to survive at least 28 days because of a pre-existing condition
- •5. Children with bacterial meningitis, bacterial endocarditis, or brain abscess
- •6. Children with complicated bone and joint infections
- •7. Children receiving antibiotics for surgical prophylaxis
- •8. Children with chronic co-morbidities, such as cystic fibrosis, chronic lung disease, bronchiectasis where there is already a pre-defined length of course of antibiotics
- •9. Children who are severely immunocompromised (e.g. chemotherapy, stem cell transplant, biological therapy for inflammatory or rheumatological conditions)
- •10. Children who in the opinion of the local investigator, are unsuitable for randomisation due to high probability of requiring sustained IV therapy
- •11. Children with a presence of existing directive to withhold life-sustaining treatment
- •12. Added 01/02/2021: Inborn infants admitted to Neonatal Intensive Care Units (NICU), Neonatal High Dependency Units (NHDU), Special Care Baby Units (SCBU) or Postnatal wards
- •Previous exclusion criteria:
- •1. Preterm infant age <37 weeks corrected gestational age or =18 years of age
- •2. Children admitted moribund and not expected to survive more than 24 hours
- •3. Children with a predicted duration of stay of less than 48 hours
- •4. Children not expected to survive at least 28 days because of a pre-existing condition
- •5. Bacterial meningitis, bacterial endocarditis, brain abscess
- •6. Children receiving antibiotics for surgical prophylaxis
- •7. Chronic co-morbidities, such as cystic fibrosis, chronic lung disease, bronchiectasis
- •8. Severe immunocompromised (e.g. chemotherapy, stem cell transplant, biological therapy for inflammatory or rheumatological conditions, TPN dependent)
- •9. Presence of existing directive to withhold life-sustaining treatment
- •10. Added 02/05/2018: Children, who in the opinion of the local investigator, are unsuitable for randomisation due to high probability of requiring long term IV therapy
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