Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

NCT01363271 | Completed

• 1 other identifier: A5951160
• Study Type: observational
• Target: 7,260
• Locations: 0 countries
• Sites: N/A

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. 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. 2.To compare the total direct medical costs of patients treated with linezolid orally or IV, or vancomycin IV for cSSSI or pneumonia hospitalization.

Conditions

Complicated Skin and Structure Infection; Nosocomial Pneumonia

Outcome Measures

Primary Outcomes (2)

• Rehospitalization

  42 days

• Total reimbursed amount following hospital discharge

  42 days

Study Arms (2)

complicated skin and skin structure infections (cSSSI)

Identified through a pre-specified list of ICD-9 codes in study protocol.

Drug: Linezolid; Drug: Vancomycin

Pneumonia

Identified through a pre-specified list of ICD-9 codes in study protocol.

Drug: Linezolid; Drug: Vancomycin

Interventions

Linezolid DRUG

IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).

complicated skin and skin structure infections (cSSSI)

Vancomycin DRUG

IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

complicated skin and skin structure infections (cSSSI)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• University of Maryland: collaborator
• Lodise & Lodise, LLC: collaborator

Related Links

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

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

Linezolid; Vancomycin

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 22, 2012

Record last verified: 2012-05