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Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Last updated on April 10, 2018

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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.
Show details

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.
Show details

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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Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Complicated Skin and Structure Infection
  • Nosocomial Pneumonia
  • 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).
  • complicated skin and skin structure infections (cSSSI)
    Identified through a pre-specified list of ICD-9 codes in study protocol.
    Interventions:
    • Drug: Linezolid
    • Drug: Vancomycin
  • Pneumonia
    Identified through a pre-specified list of ICD-9 codes in study protocol.
    Interventions:
    • Drug: Linezolid
    • Drug: Vancomycin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7260
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01363271
A5951160
No
Not Provided
Not Provided
Pfizer
Pfizer
  • University of Maryland
  • Lodise & Lodise, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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