Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

NCT01363271

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Complicated Skin and Structure Infection, Nosocomial PneumoniaCost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
NCT01363271
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
Official Title Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Complicated Skin and Structure Infection
  • Nosocomial Pneumonia
Intervention
  • 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).
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 21, 2012)
7260
Original Estimated Enrollment
 (submitted: May 27, 2011)
1
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01363271
Other Study ID Numbers A5951160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • University of Maryland, College Park
  • Lodise & Lodise, LLC
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012