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临床试验/NCT03048643
NCT03048643已完成不适用

CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

Laura Fanucchi2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Illicit drug use

研究概览

简要总结

Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more) largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional outpatient care program supporting MAT, may support provision of outpatient IV antibiotic therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due to opioid use disorder in the hospital for the full duration of antibiotic treatment) compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically stable).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • meeting OUD by DSM-V criteria
  • have IE by Duke's criteria
  • candidates for outpatient treatment with buprenorphine
  • accepting of buprenorphine treatment
  • anticipated to be discharged home after medically stabilized
  • requiring ≥ 2 weeks of IV antibiotic therapy
  • having ≥ 1 week of IV antibiotic therapy remaining at the time of medical readiness for discharge (as defined by the primary clinical team),
  • and providing informed consent.

排除标准

  • presence of stroke or central nervous system involvement
  • clinically active embolic sequelae (e.g. pulmonary sepsis, mycotic aneurysms, splenic abscesses)
  • TV treated surgically or endovascularly (AngioVac)
  • presence of osteomyelitis
  • fungal IE
  • patients who require inpatient physical rehabilitation determined by physical or occupational therapy assessment
  • current pregnancy
  • current severe methamphetamine, cocaine, alcohol or benzodiazepine use disorders by DSM-V criteria
  • currently enrolled in ongoing MAT for OUD
  • hypersensitivity or allergy to buprenorphine
  • chronic pain requiring opioids
  • class III or IV heart failure
  • cirrhosis
  • end stage renal disease
  • other significant screening laboratory/medical/psychiatric/psychosocial condition that may prevent the volunteer from safely participating in the study in the opinion of the investigator (e.g. currently suicidal)
  • pending legal action that could interfere with study participation
  • living more than a 45-minute drive from UK given the intense outpatient component to the intervention.

研究组 & 干预措施

Standard of Care

No Intervention

Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy for infective endocarditis according to usual care.

Outpatient Parenteral Antibiotic Therapy

Experimental

Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT).

干预措施: Outpatient parenteral antibiotic therapy (Behavioral)

结局指标

主要结局

Illicit drug use

时间窗: 12 weeks after discharge

Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge

次要结局

  • Completion of recommended IV antibiotic therapy(12 weeks after discharge)

研究者

发起方
Laura Fanucchi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Laura Fanucchi

Assistant Professor

University of Kentucky

研究点 (2)

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