Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Number of participants with clinical response after completion of therapy
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:
- Which group has better clinical response at end of treatment
- Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment
详细描述
Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
- •Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own
排除标准
- •Minimum inhibitory concentration (MIC) of colistin > 2 mg/L
- •Complicated infection with inadequate source controlled
- •Intracranial infection
- •Infective endocarditis
- •Intraabdominal infection
- •Bone and joint infection
- •Allergic to or have contraindication(s) to any treatment regimen in the study
- •Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)
- •Pregnancy
- •Previous treatment with colistin or fosfomycin more than 96 hours
- •Life expectancy of 24 hour or less
- •Refusal to participate in the study
- •Hospice treatment
研究组 & 干预措施
Colistin group
Participants receive intravenous colistin (colistinmethate soidum) 5 mg/kg/day (dosage will be adjusted according to creatinine clearance) and colistin nebulization at 80 mg every 8 hours in case of pneumonia.
干预措施: Colistin Sodium Methanesulfonate (Drug)
Colistin plus fosfomycin group
Participants receive intravenous colistin (colistinmethate soidum) (dosage regimen same as colistin group plus intravenous fosfomycin (dosage will be adjusted according to creatinine clearance and MIC).
干预措施: Colistin Sodium Methanesulfonate plus Fosfomycin (Drug)
结局指标
主要结局
Number of participants with clinical response after completion of therapy
时间窗: Baseline, day 10-14 (end of therapy)
Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.
次要结局
- Number of participants with clinical response at 72 hours of therapy(Baseline, day 3)
- Number of participants with microbiological cure at 72 hours of therapy(Baseline, day 3)
- Number of participants with microbiological cure after completion of therapy(Baseline, day 3)
研究者
Parichat Salee
Assistant professor Parichat sales
Chiang Mai University