EUCTR2014-004628-23-Outside-EU/EEA进行中（未招募）不适用
Comparison of Teicoplanin and Vancomycin in Terms of Efficacy and Side Effect Profile During Initial Antibiotic Treatment of Febrile Neutropenic Patients at High Risk For Gram-Positive Infection: Multi-Center, Prospective, Randomized study. - TARGOFE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. In neutropenic and febrile patients with hematological or solid tumors
- •Absolute neutrophil counts (ANC) of less than or equal to 500/mm3 in peripheral blood was considered as neutropenia Patients with absolute neutrophil counts between 500 and 1000/mm3 which was expected to fall below 500/mm3 in the next 24 hours due to chemotherapy were also be considered as neutropenic.
- •2. In order for a patient to be considered febrile, body temperature measured by oral or axillary method should be over 38.3 ºC once or over 38.0 ºC twice in at least half an hour intervals in a 12 hour period.
- •3. Patients were included in the study in their first fever attack of febrile neutropenic episodes. Therefore patients who were febrile for at least 3 days after the empirical treatment of previous febrile attack have been included in the study. Each patient was only included once in this study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 37
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 138
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Patients or legal representatives who did not provide informed consent to participate in the study
- •2. Pregnant or lactating women.
- •3. Patients previously enrolled in this study
- •4. Patients with neutropenia due to reasons other than cancer chemotherapy (i.e. aplastic anemia)
- •5. Patients in blastic phase of chronic myeloblastic leukemia
- •6. Patients with known HIV infection
- •7. Patients with central venous catheter in which prophylactic antibiotic lock” was used
- •8. Patients with possible infections due to anaerobic bacteria, fungus, mycoplasma, virus, protozoa or rickettsia.
- •9. Patients requiring initiation of concomitant anti-anaerobic, anti-viral or anti-fungal medication at the beginning of treatment
- •10. More than one dose of antimicrobial medication use 3 days prior to the use of study medications (quinolone and/or trimethoprim/sulphamethoxazole use due to bone marrow transplantation did not preclude to participate in the study).
- •11. Patients receiving antifungal fluconazole and itraconazole for treatment purposes (Patients receiving these agents for prophylactic purposes were included in the study).
- •12. Patients with a life expectancy of less than 48 hours.
- •13. Patients with lung infiltration
- •14. Patients with necrotizing colitis, liver abscess or perirectal infections
- •15. Patients with any known allergy to beta-lactam antibiotics, aminoglycosides, Vancomycin or Teicoplanin.
- •16. Patients with severe renal (serum creatinine level of >2 mg/dL or creatinine clearance of <40 ml/min) or hepatic failure (serum transaminase level of 4 times normal or higher).
- •17. Patients with alcohol or drug dependency or personality disorder or other psychological disorder that might render adherence to protocol requirements or influence the process of consent.
- •18. Patients who, within one month before this study, have used any medications for experimental purposes in some other study.
研究者
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