Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

• ClinicalTrials.gov Identifier: NCT01363271
• Recruitment Status: Completed
• First Posted: June 1, 2011
• Last Update Posted: May 22, 2012
• Sponsor: Pfizer
• Collaborators: University of Maryland, College Park; Lodise & Lodise, LLC
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 27, 2011
• First Posted Date: June 1, 2011
• Last Update Posted Date: May 22, 2012
• Study Start Date: May 2011
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2011)

• Rehospitalization [ Time Frame: 42 days ]
• Total reimbursed amount following hospital discharge [ Time Frame: 42 days ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

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

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

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 Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2012