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Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Last updated on August 8, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Skin and Structure Infection, Nosocomial Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT01363271
Pfizer
Completed
Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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