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Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

This study has been completed.
Sponsor:
Collaborators:
University of Maryland
Lodise & Lodise, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01363271
First received: May 27, 2011
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.

Condition Intervention Phase
Complicated Skin and Structure Infection
Nosocomial Pneumonia
Drug: Linezolid
Drug: Vancomycin
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Rehospitalization [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Total reimbursed amount following hospital discharge [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 7260
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
complicated skin and skin structure infections (cSSSI)
Identified through a pre-specified list of ICD-9 codes in study protocol.
Drug: Linezolid
IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).
Drug: Vancomycin
IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).
Pneumonia
Identified through a pre-specified list of ICD-9 codes in study protocol.
Drug: Linezolid
IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).
Drug: Vancomycin
IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of patients with a hospitalization for complicated skin and skin structure infections (cSSSI) or pneumonia. We will identify cases from January 1, 2007, to September 30, 2009, with additional 6 months pre-period and up to 6 months of post-index follow-up period.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363271

Sponsors and Collaborators
Pfizer
University of Maryland
Lodise & Lodise, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01363271     History of Changes
Other Study ID Numbers: A5951160
Study First Received: May 27, 2011
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Linezolid
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014