Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Conditions
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Complicated Skin and Structure Infection, Nosocomial Pneumonia

Intervention / Treatment
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* Drug: Linezolid
* Drug: Vancomycin
* Drug: Linezolid
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, 2009. 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). Exclusion Criteria: 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 18. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| complicated skin and skin structure infections (cSSSI)<br>Identified through a pre-specified list of ICD-9 codes in study protocol. | Drug: Linezolid<br>* IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).<br>Drug: Vancomycin<br>* IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).<br>|
| Pneumonia<br>Identified through a pre-specified list of ICD-9 codes in study protocol. | Drug: Linezolid<br>* IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).<br>Drug: Vancomycin<br>* IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization |  | 42 days | 
| Total reimbursed amount following hospital discharge |  | 42 days |