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临床试验/CTRI/2017/06/008829
CTRI/2017/06/008829已完成3 期

Cefepime versus Cefoperazone/Sulbactum in combination with Amikacin as empirical antibiotic therapy in cancer patients with febrile neutropenia- A randomized clinical study

Jipmer0 个研究点目标入组 334 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
Jipmer
入组人数
334

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Diagnosis of hematological or solid malignancies
  • 2. Presence of neutropenia [defined as an absolute neutrophil count (ANC) <500 cells/mm³ or if count <1000 cells/mm³ and expected to fall <500 cells/mm³ within 24â??48hours because of preceding chemotherapy
  • 3.Temperature >38ºC on two occasions at least 1 hr apart or 38.3º C on one occasion in 24 h in the absence of any other obvious cause of fever
  • 4.Both adult and pediatric FN patients
  • 5. Patients on oral antibiotic prophylaxis
  • 6.Administration of vancomycin for relavant indication will be allowed
  • 7.Previous evidence of fungal infection or patients on antifungal prophylaxis will be included

排除标准

  • 1.History of hypersensitivity reactions and severe adverse events to beta-lactam antibiotics
  • 2.prior use of any antibiotic(s) within one week of index episode
  • 3.central nerve system infection, infective endocarditis, HIV infection
  • 4.Renal dysfunction (serum creatinine >2.0 mg/dl, or creatinine clearance <60ml/min)
  • 5.Hepatic dysfunction ( total bilirubin >2 mg/dl)
  • 6.Refractory hypotension at presentation
  • 7.Lack of informed consent

研究者

发起方
Jipmer

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