Retrospective Observational Study on Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections - DALBADIA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 11
- 主要终点
- Retrospective description of the utilization of dalbavancin treatment in diabetic patients.
研究概览
简要总结
The study aims to describe the current use of dalbavancin among diabetic patients with infections in a real-world clinical setting in Italy and Spain.
详细描述
The study aims to describe the current use of dalbavancin in diabetic patients suffering from infections proven or suspected to be caused by Gram-positive or mixed Gram-positive and Gram-negative bacteria (with dalbavancin chosen for treating the Gram-positive component) in Italy and Spain.
As overall strategies to reduce the risk of developing severe infections and poor treatment outcomes among diabetic patients are under-researched and should be explored. This study could increase the knowledge of infection management among diabetic patients treated with dalbavancin in order to support appropriate clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years at the time of dalbavancin treatment initiation
- •Male and female patients
- •Patients who received dalbavancin as targeted or empirical therapy to treat Gram-positive bacterial infection or as anti-Gram-positive component of a treatment regimen for mixed infection (e.g., with concurrent antibacterial or antifungals drugs for covering Gram-negative strains or fungi)
- •Patients who received the last dose of dalbavancin according to the current standard clinical practice at least 30 (+7) days before enrolment in the study
- •Patients with known type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at the time of infectious disease of interest diagnosis
- •Patients with available retrospective data in medical charts, including information about dalbavancin treatment and diabetes history
- •Patients who gave informed consent and personal data processing consent to take part into the study following local regulation.
排除标准
- •Patients enrolled in a clinical trial in which treatment with dalbavancin was managed through a study protocol
- •Patients diagnosed with any hyperglycemic state other than T1DM or T2DM at the time of dalbavancin treatment initiation
- •Patients with long-term infection (over than 12 months of duration) at the time of dalbavancin treatment initiation
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Pregnant or breast-feeding patients from start time of dalbavancin treatment initiation till enrolment visit.
结局指标
主要结局
Retrospective description of the utilization of dalbavancin treatment in diabetic patients.
时间窗: 4 weeks
Evidence of dalbavancin treatment choice (starting and subsequent dosage)
Retrospective description of the setting of dalbavancin treatment in diabetic patients.
时间窗: 4 weeks
Evidence of dalbavancin treatment choice (setting of infusion)
Retrospective description of the dalbavancin treatment in diabetic patients.
时间窗: 4 weeks
Evidence of dalbavancin treatment choice (number and dates of infusions)
次要结局
- Demographic data(4 weeks)
- Clinical cure of dalbavancin(Up to 8 weeks)
- Incidence of Adverse Events(Up to 8 weeks)
- Microbiological success of dalbavancin(Up to 8 weeks)