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Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Skin and Structure Infection; Nosocomial Pneumonia

Intervention: Linezolid (Drug); Vancomycin (Drug); Linezolid (Drug); Vancomycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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: 1. 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. 2. To compare the total direct medical costs of patients treated with linezolid orally or IV, or vancomycin IV for cSSSI or pneumonia hospitalization.

Clinical Details

Official title: Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Rehospitalization

Total reimbursed amount following hospital discharge

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2011
Last updated: May 21, 2012

Page last updated: August 23, 2015

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