Methicillin-resistant Staphylococcus Aureus SepticemiaNCT01995760
The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
An observational study of Methicillin-resistant Staphylococcus Aureus Septicemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus Septicemia
- How many people
- 123 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2013to Jun 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients of National Taiwan University Hospital. During the period of 2001/1/1 to 2013/12/31, age above or equal to 20 year-old adult with positive methicillin-resistant Staphylococcus aureus blood culture who receiving vancomycin therapy with therapeutic monitoring.
Who may be able to join
- Inpatients of National Taiwan University Hospital
- Age above or equal to 20 years old
- Positive methicillin-resistant Staphylococcus aureus blood culture
- Receiving vancomycin therapy for definitive use
- Undergoing therapeutic drug monitoring (had serum vancomycin concentration level)
Who cannot join
- Age below 20 years old
- Without details of vancomycin dose and frequency
- Vancomycin treatment shorter than 72 hours
- Without renal function data (serum creatinine level, creatinine clearance)
- Without infection-related clinical outcomes (lab data such as white blood cell count , seg, C reactive protein , body temperature records)
- Receiving renal replacement therapy
- Therapeutic drug monitoring before reaching steady state
- With abnormal and undefined serum concentration
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.
Read the detailed description
Several studies have shown AUC/MIC to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. However, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. In 2011, Patel et al showed that highly difference between AUC(72-96h) and Cmin(96h). Different dosing and creatinine clearance may reach the same trough drug level with different AUC. The investigators wonder whether trough drug level can serve as a substitute marker for AUC and as a parameter for vancomycin therapeutic monitoring.
In this study, the investigators will calculate AUC/MIC of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level.
- Keywords
- vancomycin, therapeutic response monitoring, AUC/MIC
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)
Secondary outcomes (2)
90-day mortality
Measured: Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)
In-hospital mortality
Measured: Discharge day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-resistant Staphylococcus Aureus SepticemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Jiuan Shen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995760
- Sponsor's protocol ID
- 201310037RINA
- Status last verified
- Sep 2014
- First submitted
- 10 Nov 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
- ClinicalTrials.gov ID
- NCT01995760
- Acronym / sponsor ID
- 201310037RINA
- Keywords
- vancomycin, therapeutic response monitoring, AUC/MIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Nov 2013 (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.
The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.
Detailed description
Several studies have shown AUC/MIC to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. However, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. In 2011, Patel et al showed that highly difference between AUC(72-96h) and Cmin(96h). Different dosing and creatinine clearance may reach the same trough drug level with different AUC. The investigators wonder whether trough drug level can serve as a substitute marker for AUC and as a parameter for vancomycin therapeutic monitoring.
In this study, the investigators will calculate AUC/MIC of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients of National Taiwan University Hospital. During the period of 2001/1/1 to 2013/12/31, age above or equal to 20 year-old adult with positive methicillin-resistant Staphylococcus aureus blood culture who receiving vancomycin therapy with therapeutic monitoring.
Key inclusion criteria (5 listed)
- Inpatients of National Taiwan University Hospital
- Age above or equal to 20 years old
- Positive methicillin-resistant Staphylococcus aureus blood culture
- Receiving vancomycin therapy for definitive use
- Undergoing therapeutic drug monitoring (had serum vancomycin concentration level)
Key exclusion criteria (8 listed)
- Age below 20 years old
- Without details of vancomycin dose and frequency
- Vancomycin treatment shorter than 72 hours
- Without renal function data (serum creatinine level, creatinine clearance)
- Without infection-related clinical outcomes (lab data such as white blood cell count , seg, C reactive protein , body temperature records)
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
30-day mortality
Time frame: Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)
2 secondary outcomes
90-day mortality
Time frame: Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)
In-hospital mortality
Time frame: Discharge day
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 4 Sep 2014.
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Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis
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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.
Li-Jiuan Shen principal investigator
National Taiwan University Hospital
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 Methicillin-resistant Staphylococcus Aureus Septicemia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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 4 Sep 2014. 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 Taiwan. 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 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?
30-day mortality (time frame: Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)). 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 4 Sep 2014.