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临床试验/ACTRN12622001063707
ACTRN12622001063707招募中未知

BEAT CF: Pulmonary Exacerbations Treatment Platform - Adjunct Antibiotics Domain:An evaluation of the comparative effectiveness of prescribing various standard of care, adjunct Antibiotics in the management of pulmonary exacerbations requiring intensive therapy (PERIT) in children and adults with CF, with respect to their short-term improvement in lung function.

niversity of Sydney0 个研究点目标入组 5,000 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
5,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
5 Years 至 o limit(—)
性别
All

入选标准

  • 1. Be enrolled in the BEAT CF PEx Cohort (ACTRN12621000638831).
  • 2. Documented informed consent to participate in the Adjunct antibiotic Domain.
  • 3. Are eligible for at least two Interventions in the Adjunct Antibiotic Domain available at the clinical Site (including no Adjunct Antibiotic).
  • 4. Must be able to reliably perform spirometry.

排除标准

  • 1. The person is unable to reliably perform spirometry (for example due to young age)
  • 2. The person’s Responsible Clinician deems enrolment in the PEx Adjunct Antibiotic Domain is not in their best interest.
  • A participant will be excluded from Assignment to a specific Intervention in the Adjunct Antibiotic Domain if:
  • 1. They have a known or suspected significant drug hypersensitivity to tobramycin or other aminoglycosides
  • 2. Recognised contraindication to IV tobramycin, including known renal, auditory or vestibular impairment which, in the opinion of the Responsible Clinician, precludes its use.
  • 3. The Intervention is deemed unacceptable by the Responsible Clinician e.g. because of a poor treatment response to that antibiotic (requiring a change in antibiotic treatment) in the preceding 12 months

研究者

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