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OpenTrials
Completed

NCT Number: NCT01363271

Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linezolid

Drug

IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).

Vancomycin

Drug

IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

Primary outcomes

  1. Rehospitalization

    Time frame: 42 days

  2. Total reimbursed amount following hospital discharge

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Lodise & Lodise, LLC
  • University of Maryland

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 1, 2011
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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