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临床试验/ISRCTN51731976
ISRCTN51731976已完成3 期

Tackling early morbidity and mortality in myeloma: assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections

niversity of Birmingham (UK)0 个研究点目标入组 977 人开始时间: 2011年8月10日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
977

研究概览

简要总结

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31668592 (added 04/11/2019) 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31690402 (added 08/11/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged minimum of 21 years and able to give informed consent
  • 2. Patient with newly diagnosed symptomatic myeloma based on internationally agreed criteria, within 7 days of starting a programme of anti-myeloma therapy (or within 14 days of starting anti-myeloma therapy if already on a broad spectrum antibacterial agent)
  • 3. Provision of written informed consent
  • 4. Male or female participants

排除标准

  • 1. Patients with contraindication to Levofloxacin:
  • 1.1. Known to have sensitivity/allergy to Levofloxacin or other quinolones
  • 1.2. Patients with a history of tendon disorders related to fluoroquinolone administration
  • 1.3. Patients receiving other prophylactic antibiotic treatment (excluding pneumocystis prophylaxis if regarded as essential)
  • 1.4. Patients receiving amiodarone or arsenic trioxide
  • 1.5. Patients on active antiepileptic treatment
  • 2. Women of childbearing age who are not willing to use appropriate methods of contraception to prevent pregnancy or women that are breastfeeding
  • 3. Patient thought to have mandatory requirement for prophylactic antibiotics
  • 4. Patient who is not going to receive anti myeloma therapy

研究者

发起方
niversity of Birmingham (UK)

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