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临床试验/NCT02961764
NCT02961764已完成4 期

A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

Allergan11 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2016年11月29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
313
试验地点
11
主要终点
Hospital Admission Rate at Initial Episode of Care

研究概览

简要总结

This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.

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

  • Presents to the Emergency Department (ED) and 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

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)

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)

结局指标

主要结局

Hospital Admission Rate at Initial Episode of Care

时间窗: 44 Days

次要结局

  • 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(Day 14)
  • Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay(Day 14)
  • Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV(14 Days)
  • Number of Participants With Infection-related Hospitalizations(44 Days)
  • Patient Satisfaction With Care: Overall Health(Day 14)
  • Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day(Day 14)
  • Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV(14 days)
  • Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV(14 Days)
  • Number of Infection-related Total Admitted Hospital Days(44 Days)
  • Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit(44 Days)
  • Number of Participants With Infection-related Outpatient Healthcare Visits(44 Days)
  • Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV(Day 14)
  • Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living(Day 14)
  • Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care(14 Days)
  • Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV(Day 14)
  • Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care(Initial Care: 14 Days)
  • Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time(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 Serious Adverse Events (SAEs)(44 Days)
  • Patient Satisfaction With Care: Wait in Emergency Room(Day 14)
  • Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy(Day 14)
  • Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire(Day 14)
  • Number of Total Admitted Hospital Days(44 Days)
  • Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED(Follow-up: 30 Days)
  • Patient Satisfaction With Care: Satisfaction With Hospital Stay(Day 14)
  • Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections(Day 14)
  • Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy(Day 14)
  • Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV(Day 14)
  • Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider(14 days)
  • Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV(Day 14)
  • Patient Satisfaction With Care: Find Value in a Physician(Day 14)
  • 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 (11)

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