Complicated Skin and Structure InfectionNCT01363271
Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
An observational study of Complicated Skin and Structure Infection and Nosocomial Pneumonia, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Complicated Skin and Structure Infection, Nosocomial Pneumonia
- What is being tested?
- Linezolid and Vancomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 7,260 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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:
- 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.
- To compare the total direct medical costs of patients treated with linezolid orally or IV, or vancomycin IV for cSSSI or pneumonia hospitalization.
Read the 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.
- Being tested
- Linezolid, Vancomycin
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).
VancomycinDrug
IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).
LinezolidDrug
IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).
VancomycinDrug
IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).
| Study group | Role | What they receive |
|---|---|---|
| complicated skin and skin structure infections (cSSSI) | Identified through a pre-specified list of ICD-9 codes in study protocol. Receives: Drug: Linezolid; Drug: Vancomycin | |
| Pneumonia | Identified through a pre-specified list of ICD-9 codes in study protocol. Receives: Drug: Linezolid; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization
Measured: 42 days
Total reimbursed amount following hospital discharge
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Skin and Structure InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Lodise & Lodise, LLC
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363271
- Sponsor's protocol ID
- A5951160
- Status last verified
- May 2012
- First submitted
- 27 May 2011
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01363271
- Acronym / sponsor ID
- A5951160
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,260 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Lodise & Lodise, LLC
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complicated skin and skin structure infections (cSSSI) | – | Drug: Linezolid, Drug: VancomycinIdentified through a pre-specified list of ICD-9 codes in study protocol. |
| Pneumonia | – | Drug: Linezolid, Drug: VancomycinIdentified through a pre-specified list of ICD-9 codes in study protocol. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinezolidIV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs). | Drug | complicated skin and skin structure infections (cSSSI) |
| VancomycinIV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs). | Drug | complicated skin and skin structure infections (cSSSI) |
| LinezolidIV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs). | Drug | Pneumonia |
| VancomycinIV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs). | Drug | Pneumonia |
Primary outcome
Rehospitalization
Time frame: 42 days
Total reimbursed amount following hospital discharge
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Skin and Structure Infection and Nosocomial Pneumonia, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2012.