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; Lodise & Lodise, LLC
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Complicated Skin and Structure Infection; Nosocomial Pneumonia	Drug: Linezolid; Drug: Vancomycin

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 Design

• Study Type: Observational
• Actual Enrollment: 7260 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
• Study Start Date: May 2011
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: May 2012

Groups and Cohorts

Group/Cohort	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

1. Rehospitalization [ Time Frame: 42 days ]
2. Total reimbursed amount following hospital discharge [ Time Frame: 42 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Pfizer

University of Maryland

Lodise & Lodise, LLC

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01363271
• Other Study ID Numbers: A5951160
• First Posted: June 1, 2011
• Last Update Posted: May 22, 2012
• Last Verified: May 2012

Additional relevant MeSH terms:

Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Vancomycin; Linezolid; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action