Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To assess cardiac re-operation.
研究概览
简要总结
The purpose of this study is to determine the safety and compliance of initial intravenous (IV) antibiotics followed by oral antibiotic therapy following uncomplicated IVDA endocarditis. Endocarditis has a high rate of sickness and death, involves a long hospitalization and a long-term use of IV antibiotics necessitating six (6) weeks of in-patient hospital stay, and comes with a high cost.
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
- •The age of the patient is ≥
- •The patient has undergone an urgent or emergent primary cardiac valvar operation as treatment for IVDA endocarditis, with blood cultures positive for Streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative Staphylococci
- •The patient has received 2 weeks of postoperative inpatient IV antibiotic therapy with negative blood cultures and no residual active infection by imaging (i.e. computerized axial tomography, echocardiography)
- •The patient has the capacity to participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile Medisafe compliance https://www.medisafe.com/) as confirmed by both a physician and a care management team member
排除标准
- •Inability to give informed consent
- •Residual infection requiring IV antibiotic therapy
- •Any persistent secondary noncardiac infection (e.g. infections of solid organs or joints)
- •Known poor compliance or deemed incapable to comply with the compliance tracking tool
- •Reduced absorption or inability to receive oral treatment due to a gastrointestinal disorder
- •Any infection involving a more virulent organisms, such as fungal infections or infections with Serratia or HACEK infections (Haemophilus, Aggregatibacter, Cardiobacterium, Eikenella, Kingella).
- •Cancer not otherwise in remission or in need of current or future oncologic therapy
- •Medically immunocompromised state
- •Reoperative valvar operation for IVDA endocarditis
- •History of habitual noncompliance
- •Pregnancy
- •Mental incapacity
- •Unable to perform local or institutional medical and psychiatric follow up
- •Unstable home environment
- •Inadequate access to mobile cell service (geographic/rurality)
研究组 & 干预措施
Group I (Experimental)
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
干预措施: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin (Drug)
Group I (Experimental)
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
干预措施: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline (Drug)
Group II (Control Group)
Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).
干预措施: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline (Drug)
结局指标
主要结局
To assess cardiac re-operation.
时间窗: One year
To assess cardiac re-operation.
To assess all-cause mortality at (12) months post-surgery.
时间窗: One year
To assess all-cause mortality at (12) months post-surgery.
To assess recurrent blood culture positive infection.
时间窗: One year
To assess recurrent blood culture positive infection.
To assess all-cause mortality at six (6) months post-surgery.
时间窗: Six months
To assess all-cause mortality at six (6) months post-surgery.
次要结局
- Cost of care(Through study completion, an average of one year)
- Readmission for recurrent infection or cardiac re-operation(One year)
研究者
Vinay Badhwar
Executive Chair, Heart & Vascular Institute
West Virginia University