Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Clostridium Difficile Infection Occurrence
研究概览
简要总结
The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.
详细描述
Clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. Current practice throughout the United States is targeted at infection prevention measures such as hand washing and isolation. Despite these measures, incidence of Clostridium difficile infections continue to rise as some institutions, including our own. Recently, a study published in Clinical Infectious Diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. No studies to date have evaluated primary prophylaxis with oral vancomycin. This will be a single center, prospective study to evaluate oral vancomycin use as primary Clostridium difficile prophylaxis. Patients treated by infectious disease physicians will be identified as "high risk" and after pager notification the ID physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. Risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. Oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for Clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •"High-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics
- •Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists
- •Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem
排除标准
- •Failure to meet all three requirements for "high risk"
- •Vancomycin allergy
- •Active clostridium difficile infection prior to inclusion
- •Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper)
- •Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin)
- •Pregnant or breastfeeding
研究组 & 干预措施
Vancomycin Oral
This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Intervention type: drug, vancomycin 125 mg daily
干预措施: Vancomycin Oral (Drug)
结局指标
主要结局
Clostridium Difficile Infection Occurrence
时间窗: Within 4 weeks from the completion of antibiotic treatment
The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.
次要结局
- Clostridium Difficile Infection Severity(Within 4 weeks from completion of antibiotic treatment)
- Time to Clostridium Difficile Infection Occurence(Within 4 weeks from completion of antibiotic treatment)
研究者
Ryan Medas
PGY2 Pharmacy Internal Medicine Resident
St. Luke's Hospital, Chesterfield, Missouri
