Cefotetan Therapy for Escherichia Coli Bacteremia and Genitourinary Infections: a Prospective Phase II Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
This pilot study will compare clinical outcomes among patients treated with cefotetan versus standard of care antibiotics for bacteremia or genitourinary infections caused by E. coli. It will also measure cefotetan minimum inhibitory concentration (MIC) distributions and cefotetan trough serum concentrations.
详细描述
In this single-center pilot trial, we will study the efficacy of cefotetan versus standard of care antibiotic therapy for patients hospitalized at Oregon Health & Science University (OHSU) with bacteremia caused by extended-spectrum β-lactamase-producing (ESBL) and non-ESBL E. coli with a genitourinary source. Participants who consent for enrollment will be randomized 1:1 to receive either cefotetan or standard of care antibiotic therapy for their infection and followed for 30 days to determine clinical outcomes. In addition, we will measure cefotetan MIC distributions among patients with ESBL bloodstream or genitourinary infections. Finally, we will measure cefotetan trough serum concentrations in a subset of enrolled patients with ESBL and non-ESBL E. coli bacteremia who are treated with cefotetan.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(clinical cohort):
- •Identified within 48 hours of inpatient antibiotic administration for acute illness.
- •Patient or legally authorized representative are able to provide informed consent for participation in the study.
- •Monomicrobial E. coli bacteremia with a genitourinary source.
- •Isolate susceptible to both ertapenem and cefotetan (ESBL infections) or ceftriaxone and cefotetan (non-ESBL infections).
排除标准
- •(clinical cohort):
- •Allergy to cefotetan.
- •History of cephalosporin-associated hemolytic anemia.
- •Allergy to ertapenem or meropenem (among patients with ESBL E. coli infections).
- •Allergy to ceftriaxone (among patients with non-ESBL E. coli infections). Includes allergy to antibiotics with a similar structure expected to confer cross reactivity to ceftriaxone (cefotaxime, cefpodoxime, ceftazidime).
- •Admission within 30 previous days.
- •Any bacteremia with the same organism in the previous 90 days.
- •Pregnant or breastfeeding.
- •Moderately to severely immunocompromised, including solid organ or stem cell transplant, hematologic malignancy, active chemotherapy.
- •Admission with neutropenic fever.
- •Severe illness, including shock and/or intensive care unit admission.
- •Inability to complete at least 72 hours of appropriate parenteral therapy, including at least 1 dose cefotetan for patients randomized to the treatment arm or at least 1 dose of appropriate parenteral therapy following randomization for patients assigned to the standard of care arm.
研究组 & 干预措施
Cefotetan
干预措施: Cefotetan (Drug)
Standard of care antibiotics
干预措施: Carbapenems (Drug)
Standard of care antibiotics
干预措施: Beta Lactam Antibiotics (Drug)
结局指标
主要结局
Clinical success
时间窗: From randomization through 30 days.
Absence of death, recurrent E. coli, bacteremia, or need for antibiotic treatment for recurrent E.coli genitourinary infection.
次要结局
- Cefotetan MIC(Baseline)
- Cefotetan trough(Day 1 through 7)
研究者
Kristina Bajema
Assistant Professor of Medicine
Oregon Health and Science University