Staphylococcus AureusNCT00862862
Evaluation of Vancomycin Treatment of Infections Due to Staphylococcus Aureus
An observational study of Staphylococcus Aureus, run by University of Nebraska at 1 site in United States.
Trial summary
Objective: The objective of the study is to evaluate the ability of current vancomycin dosing strategies to attain the pharmacodynamic target of an area under the curve (AUC) to minimum inhibitory concentration (MIC) ratio greater than 400:1 for patients with a suspected or documented Staphylococcus aureus infection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Staphylococcus Aureus
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 3 Feb 2011
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with suspected or documentd staphylcoccus aureus infection and prescribed vancomycin
Who may be able to join
- 19 years of age or older
- Admitted to an inpatient care unit at The Nebraska Medical Center
- Prescribed intravenous vancomycin therapy with a dosing interval of 24 hours or less
- Vancomycin therapy that lasts for at least 3 doses or 5 half-lives as scheduled with no dosage changes
Who cannot join
- Estimated creatinine clearance (CrCl) less than 30 ml/min using the Cockroft-Gault equation (in patients over the age of 65 a SCr of 1.0 mg/dL will be assumed for all patients with a reported SCr less than 1.0 mg/dL). Ideal body weight will be used for the Cockroft-Gault equation unless the actual body weight is less than the ideal body weight.
- Patients requiring any form of dialysis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Evaluation of Pharmacodynamic Target Attainment With Vancomycin Treatment of Infections Due to Staphylococcus Aureus
Objective: The objective of the study is to evaluate the ability of current vancomycin dosing strategies to attain the pharmacodynamic target of an area under the curve (AUC) to minimum inhibitory concentration (MIC) ratio greater than 400:1 for patients with a suspected or documented Staphylococcus aureus infection.
Primary Outcome: The primary outcome is the percentage of vancomycin dosing regimens that achieve AUC:MIC ratio > 400 on the first occurrence of vancomycin use in patients with a suspected or documented S. aureus infection at The Nebraska Medical Center.
Read more
Secondary Outcomes:
- To assess the probability that vancomycin AUC:MIC ratios obtained from The Nebraska Medical Center patients exceed a therapeutic threshold using S. aureus MICs from isolates obtained from The Nebraska Medical Center.
- Using MIC data from the TRUST Study database (large national surveillance database) and the vancomycin AUC data obtained from TNMC patients, perform a Monte Carlo analysis that will assess the probability of achieving a therapeutic vancomycin threshold with a large number of isolates.
Read the detailed description
Study Design: This is a prospective cohort study with a retrospective chart review component.
Inclusion and Exclusion Criteria: Inpatients of The Nebraska Medical Center will be included if they are 19 years of age or older, prescribed intravenous vancomycin therapy with a dosing interval of 24 hours or less, and therapy is continued for at least 3 doses or five half lives. Exclusion criteria consists of an estimated creatinine clearance less than 30 ml/min, concurrent use of dialysis, and pregnancy.
Interventions: For the prospective component eligible patients will be consented and enrolled. A vancomycin trough level will be determined as normal standard of care thirty minutes prior to the appropriate vancomycin dose, followed by a vancomycin peak level one hour after the end of the infusion. Serum concentration time data will then be used to calculate an AUC. The retrospective component of the study will involve a chart review of patients treated with vancomycin in which a serum trough and peak level was obtained and calculation of the AUC as described.
Evaluations: Serum concentration time data will be used to calculate an AUC for each patient enrolled in the study and from all charts reviewed that meet criteria. MIC data will be determined for Staphylococcus aureus isolates obtained from The Nebraska Medical Center. The two sets of data will then be used to calculate an AUC:MIC ratio. The AUC:MIC data will be compared to the goal ratio of greater than 400. Additionally, using the AUC data from our patients and the MICs derived from a large national surveillance data base, a Monte Carlo analysis will be completed to determine the probability of achieving therapeutic ratios.
- Conditions
- Staphylococcus Aureus
- Keywords
- infection, staphylococcus aureus, vancomycin, pharmacodynammics
- Medical subject headings
- Staphylococcal Infections, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vancomycin dosing regimens achieving AUC:MIC ratio > 400
The primary outcome is the percentage of vancomycin dosing regimens that achieve AUC:MIC ratio > 400 on the first occurrence of vancomycin use in patients with a suspected or documented S. aureus infection at The Nebraska Medical Center.
Measured: 12 months
Secondary outcomes (1)
Therapeutic vancomycin threshold
Using MIC data from the TRUST Study database and the vancomycin AUC data obtained from TNMC patients, perform a Monte Carlo analysis that will assess the probability of achieving a therapeutic vancomycin threshold with a large number of isolates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study start1 Apr 2009
- Primary completion3 Feb 2011
- Study completion3 Feb 2011
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith M Olsen, PharmD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862862
- Sponsor's protocol ID
- 0002-09-FB
- Status last verified
- Aug 2023
- First submitted
- 13 Mar 2009
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacodynamic Target Attainment With Vancomycin Treatment of Infections Due to Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT00862862
- Acronym / sponsor ID
- 0002-09-FB
- Conditions
- Staphylococcus Aureus
- Keywords
- infection, staphylococcus aureus, vancomycin, pharmacodynammics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 3 Feb 2011 (actual)
- Study completion
- 3 Feb 2011 (actual)
- First posted
- 17 Mar 2009 (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.
Objective: The objective of the study is to evaluate the ability of current vancomycin dosing strategies to attain the pharmacodynamic target of an area under the curve (AUC) to minimum inhibitory concentration (MIC) ratio greater than 400:1 for patients with a suspected or documented Staphylococcus aureus infection.
Primary Outcome: The primary outcome is the percentage of vancomycin dosing regimens that achieve AUC:MIC ratio > 400 on the first occurrence of vancomycin use in patients with a suspected or documented S. aureus infection at The Nebraska Medical Center.
Secondary Outcomes:
- To assess the probability that vancomycin AUC:MIC ratios obtained from The Nebraska Medical Center patients exceed a therapeutic threshold using S. aureus MICs from isolates obtained from The Nebraska Medical Center.
- Using MIC data from the TRUST Study database (large national surveillance database) and the vancomycin AUC data obtained from TNMC patients, perform a Monte Carlo analysis that will assess the probability of achieving a therapeutic vancomycin threshold with a large number of isolates.
Detailed description
Study Design: This is a prospective cohort study with a retrospective chart review component.
Inclusion and Exclusion Criteria: Inpatients of The Nebraska Medical Center will be included if they are 19 years of age or older, prescribed intravenous vancomycin therapy with a dosing interval of 24 hours or less, and therapy is continued for at least 3 doses or five half lives. Exclusion criteria consists of an estimated creatinine clearance less than 30 ml/min, concurrent use of dialysis, and pregnancy.
Interventions: For the prospective component eligible patients will be consented and enrolled. A vancomycin trough level will be determined as normal standard of care thirty minutes prior to the appropriate vancomycin dose, followed by a vancomycin peak level one hour after the end of the infusion. Serum concentration time data will then be used to calculate an AUC. The retrospective component of the study will involve a chart review of patients treated with vancomycin in which a serum trough and peak level was obtained and calculation of the AUC as described.
Evaluations: Serum concentration time data will be used to calculate an AUC for each patient enrolled in the study and from all charts reviewed that meet criteria. MIC data will be determined for Staphylococcus aureus isolates obtained from The Nebraska Medical Center. The two sets of data will then be used to calculate an AUC:MIC ratio. The AUC:MIC data will be compared to the goal ratio of greater than 400. Additionally, using the AUC data from our patients and the MICs derived from a large national surveillance data base, a Monte Carlo analysis will be completed to determine the probability of achieving therapeutic ratios.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected or documentd staphylcoccus aureus infection and prescribed vancomycin
Key inclusion criteria (4 listed)
- 19 years of age or older
- Admitted to an inpatient care unit at The Nebraska Medical Center
- Prescribed intravenous vancomycin therapy with a dosing interval of 24 hours or less
- Vancomycin therapy that lasts for at least 3 doses or 5 half-lives as scheduled with no dosage changes
Key exclusion criteria (3 listed)
- Estimated creatinine clearance (CrCl) less than 30 ml/min using the Cockroft-Gault equation (in patients over the age of 65 a SCr of 1.0 mg/dL will be assumed for all patients with a reported SCr less than 1.0 mg/dL). Ideal body weight will be used for the Cockroft-Gault equation unless the actual body weight is less than the ideal body weight.
- Patients requiring any form of dialysis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of vancomycin dosing regimens achieving AUC:MIC ratio > 400
Time frame: 12 months
The primary outcome is the percentage of vancomycin dosing regimens that achieve AUC:MIC ratio > 400 on the first occurrence of vancomycin use in patients with a suspected or documented S. aureus infection at The Nebraska Medical Center.
1 secondary outcome
Therapeutic vancomycin threshold
Time frame: 12 months
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
Keith M Olsen, PharmD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus, run by University of Nebraska at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: lack of enrollment). Results are not available in the source record.
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?
Percentage of vancomycin dosing regimens achieving AUC:MIC ratio > 400 (time frame: 12 months). 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 23 Aug 2023.