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