Comparison of Efficacy and Safety of Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii: Utility of the Synergy Test Results (E-test) in Vitro
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- microbiologic response
研究概览
简要总结
The investigators aimed to confirm the utility of the synergy test results (E-tesT) in vitro to predict the efficacy and safety of colistin-rifampin combination and colistin monotherapy in extensively drug-resistant acinetobacter baumannii.
详细描述
We will searched pneumonia patients with CoRAB in Gangnam Severance Hospital. Subjects will be enrolled and randomized in a blinded fashion using a computerized random number generator (permuted-block randomization) for treatment with colistin and rifampin combination and colistin only at a ratio of 1:1. We will perform the E-test MIC:MIC ratio method to predict in vitro synergy of colistin and rifampin combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pneumonia, blood septicemia, urinary tract infection, or other infection or even colonization with evidence of extensively drug-resistant Acinetobacter baumannii infection
排除标准
- •Hypersensitivity reaction to colistin or rifampin
- •use of colistin or rifampin in 15 days prior to screening
- •evidence of extensively drug-resistant Acinetobacter baumannii infection in 15 days prior to screening
- •CLcr < 15 mL/min, ALT or AST > 3xULN, total bilirubin > 2xULN, Hb < 7 gm/dL, ANC < 500/mm3, Platelet < 50,000/mm3
研究组 & 干预措施
colistin monotherapy
The subjects will be treated with colistin monotherapy. Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval. Treatment should be maintained daily administration for at least 7 days and up to 28 days. Duration of antibiotics treatment will be determined through discussion by pulmonology and infection specialist.
干预措施: colistin monotherapy (Drug)
colistin-rifampin combination
The subjects will be treated with colistin and rifampin combination therapy. Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval. Rifampin (600 mg, rifampin, Yuhan, Seoul, Korea) will be orally administered daily. Treatment should be maintained daily administration for at least 7 days and up to 28 days. Duration of antibiotics treatment will be determined through discussion by pulmonology and infection specialist.
干预措施: colistin and rifampin combination therapy (Drug)
结局指标
主要结局
microbiologic response
时间窗: 14 days
negative conversion of culture study (eradication)
次要结局
- clinical response(14 days)
- mortality(30 days)
研究者
Min Kwang Byun
Assisstant Professor
Gangnam Severance Hospital