Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 801
- 主要终点
- - Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation)
研究概览
简要总结
The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease.
- •Fever (>38ºC)
- •Neutropenia (absolute neutrophil count < 500 or < 1000 anticipated to fall below 500 cells within 24-48 hours).
排除标准
- •Known allergy to any of the antibiotics used in this trial
- •A high probability of death within 48 hours
结局指标
主要结局
- Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation)
时间窗: 3 months
- Safety evaluation:during the empirical therapy
次要结局
- Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)(3 Months)