跳至主要内容
临床试验/NCT03233438
NCT03233438已完成4 期

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections

Allergan1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2017年7月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Allergan
入组人数
91
试验地点
1
主要终点
Number of Infection-related Total Admitted Hospital Days

研究概览

简要总结

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • Admitted patients who meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
  • Known or suspected gram-positive infection.

排除标准

  • Known or suspected gram-negative infections, anaerobic infections, or fungemia
  • Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance
  • Injection drug users with a fever
  • Severe neurological disorder leading to immobility or confined to a wheelchair
  • Bilateral Lower extremity involvement of the suspected infection.

研究组 & 干预措施

New Critical Pathway

Active Comparator

The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.

干预措施: Dalbavancin (Drug)

Usual Care

Active Comparator

Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.

干预措施: Usual Care (Drug)

结局指标

主要结局

Number of Infection-related Total Admitted Hospital Days

时间窗: 44 Days

次要结局

  • Number of Participants With Infection-related Hospitalizations(44 Days)
  • Number of Participants With Infection-related Emergency Department (ED) Visits(44 Days)
  • Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy(44 Days)
  • Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy(44 Days)
  • Patient Satisfaction With Care: Hospitalization(14 Days)
  • Number of Total Admitted Hospital Days(44 Days)
  • Patient Satisfaction With Care: Satisfaction With Hospital Stay(14 Days)
  • Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy(14 Days)
  • Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV(14 Days)
  • Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV(14 Days)
  • Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living(14 Days)
  • Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy(14 Days)
  • Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time(44 Days)
  • Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital(Follow-up: 30 Days)
  • Patient Satisfaction With Care: Overall Health(14 Days)
  • Patient Satisfaction With Care: Wait in Emergency Room(14 Days)
  • Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections(14 Days)
  • Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV(14 Days)
  • Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit(44 Days)
  • Number of Participants With Infection-related Outpatient Healthcare Visits(44 Days)
  • Change From Baseline in Response to Treatment at End of Treatment Visit(Baseline, Day 14)
  • Number of Participants With Serious Adverse Events (SAEs)(44 Days)
  • Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay(14 Days)
  • Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire(Day 10-14)
  • Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV(14 Days)
  • Healthcare Costs(44 Days)
  • Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV(14 Days)
  • Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day(14 Days)
  • Patient Satisfaction With Care: Find Value in a Physician(14 Days)
  • Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire(Day 14)

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验