Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7,260
- 主要终点
- Rehospitalization
研究概览
简要总结
This is a retrospective, observational, non-interventional drug study using de-identified data from two administrative claims datasets. The study design and analysis will reflect the perspective of the commercially insured. The objectives of this study are twofold:
- To compare the rates of re-hospitalization among patients treated with either linezolid orally or IV, or vancomycin IV for complicated skin and skin structure infections (cSSSI) or pneumonia hospitalization.
- To compare the total direct medical costs of patients treated with linezolid orally or IV, or vancomycin IV for cSSSI or pneumonia hospitalization.
详细描述
A sampling method is not used in this study since it is a retrospective, non-interventional claims database analysis. Pre-specified inclusion/exclusion criteria and ICD-9, NDC, HCPC codes are applied to identify the study cohorts.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Patients with a hospitalization for cSSSI or pneumonia for which the discharge date (i.e. index date) is between January 1, 2007 and September 30,
- •Patient must have a claim for either vancomycin (IV) or linezolid (IV or oral) within 7 days following their cSSSI or pneumonia hospitalization discharge date (i.e. index date). We will exclude patients who initially receive both vancomycin and linezolid on the same day. We will apply an intention-to-treat approach and use the first drug as the index drug, even if the "comparator drug" (e.g. vancomycin for linezolid and vice-versa) is used subsequently on a future date. If there are both oral and IV formulations of the same index drug on the same index date, the patient will be kept and categorized as an IV user. As with all duplicate claims, for two claims that have both oral and IV index drug as well as the same IV and oral costs on the same index date, the claim with the oral drug will be removed, and the patient will be called an IV user.
- •18-64 years of age at index date.
- •Continuous eligibility for six months prior to the index hospitalization date. No minimum of post-index continuous enrolment is required to assure that early mortality patients are included (maximum of 180 days after the index vancomycin or linezolid claim).
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Patients who were enrolled in Medicare.
- •Patients who were over age 65 or younger than
- •Patients with fewer than 3 days of oral therapy.
- •Patients with index hospitalization of greater than 30 days.
- •Patients with osteomyelitis, infective endocarditis, meningitis, joint infections, necrotizing fasciitis, gangrene, prosthetic joint infection, or prosthetic implant/ device infection during index hospitalization.
研究组 & 干预措施
complicated skin and skin structure infections (cSSSI)
Identified through a pre-specified list of ICD-9 codes in study protocol.
干预措施: Linezolid (Drug)
complicated skin and skin structure infections (cSSSI)
Identified through a pre-specified list of ICD-9 codes in study protocol.
干预措施: Vancomycin (Drug)
Pneumonia
Identified through a pre-specified list of ICD-9 codes in study protocol.
干预措施: Linezolid (Drug)
Pneumonia
Identified through a pre-specified list of ICD-9 codes in study protocol.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Rehospitalization
时间窗: 42 days
Total reimbursed amount following hospital discharge
时间窗: 42 days
次要结局
未报告次要终点