MRSA - Methicillin Resistant Staphylococcus Aureus InfectionPhase 4CIVNCT01786161
Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
A Phase 4 study testing Vancomycin continuous infusion and Vancomycin intermittent dosing interval in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA - Methicillin Resistant Staphylococcus Aureus Infection
- What is being tested?
- Vancomycin continuous infusion and Vancomycin intermittent dosing interval
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with suspected infection
- Calculated creatinine clearance > 60ml/min
Who cannot join
- Age < 18 years
- Allergic to vancomycin
- Calculated creatinine clearance < 60ml/min
- Pregnant
- Vancomycin administration more than 8 hour and less than 24 hour prior to study enrollment
- Anticipated vancomycin treatment less than 2 days for surgical prophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection.
Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.
Read the detailed description
Early administration of effective antibiotics is the cornerstone of management in septic patients; however, altered pharmacokinetics in critically ill patients has lead to subtherapeutic antibiotic exposure with standard antibiotic dosing and administration. This is further evidenced by low therapeutic target achievement with our intermittent vancomycin dosing nomogram. Administering vancomycin by continuous infusions may lead to achieving a therapeutic concentration and AUC24 more quickly than the administration by intermittent infusions as well as provide a more consistent concentration throughout the dosing period. Therefore, a new vancomycin continuous infusion nomogram was developed to increase the achievement of a goal vancomycin concentration within 24 hours.
We hypothesized that vancomycin administered as continuous infusion would achieve the therapeutic target sooner and more consistently than when administered as an intermittent infusion in critically ill surgical patients. The aims of this study were to determine the dosing differences between continuous (CIV) and intermittent (IIV) dosing in critically ill surgical intensive care unit (SICU) patients with preserved renal function and whether calculated Cockcroft-Gault Creatinine Clearance (CG CrCL) or measured creatinine clearance (CrCL) is a better predictor of vancomycin clearance.
- Being tested
- Vancomycin continuous infusion, Vancomycin intermittent dosing interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin continuous infusionDrug
Vancomycin 24 hour intravenous continuous infusion
Vancomycin intermittent dosing intervalDrug
Vancomycin intravenous infusion at rate 1000mg/hr
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin with continuous infusion | Experimental | 24 hours continuous infusion Receives: Drug: Vancomycin continuous infusion |
| Vancomycin with intermittent dose interval | Active comparator | infusion rate 1000mg/hr Receives: Drug: Vancomycin intermittent dosing interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved the Target Vancomycin Concentration
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Measured: 24 hours
Secondary outcomes (2)
Time Required to Reach the Therapeutic Levels
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Measured: as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)
Vancomycin Concentration at 24 Hours
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MRSA - Methicillin Resistant Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin Jung Lin, Massachusetts General Hospital
- Investigators
- Hsin Lin, PharmD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786161
- Sponsor's protocol ID
- P 002617
- Acronym
- CIV
- Status last verified
- May 2017
- First submitted
- 4 Feb 2013
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
- ClinicalTrials.gov ID
- NCT01786161
- Acronym / sponsor ID
- CIV / P 002617
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection.
Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.
Detailed description
Early administration of effective antibiotics is the cornerstone of management in septic patients; however, altered pharmacokinetics in critically ill patients has lead to subtherapeutic antibiotic exposure with standard antibiotic dosing and administration. This is further evidenced by low therapeutic target achievement with our intermittent vancomycin dosing nomogram. Administering vancomycin by continuous infusions may lead to achieving a therapeutic concentration and AUC24 more quickly than the administration by intermittent infusions as well as provide a more consistent concentration throughout the dosing period. Therefore, a new vancomycin continuous infusion nomogram was developed to increase the achievement of a goal vancomycin concentration within 24 hours.
We hypothesized that vancomycin administered as continuous infusion would achieve the therapeutic target sooner and more consistently than when administered as an intermittent infusion in critically ill surgical patients. The aims of this study were to determine the dosing differences between continuous (CIV) and intermittent (IIV) dosing in critically ill surgical intensive care unit (SICU) patients with preserved renal function and whether calculated Cockcroft-Gault Creatinine Clearance (CG CrCL) or measured creatinine clearance (CrCL) is a better predictor of vancomycin clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin with continuous infusion | Experimental | Drug: Vancomycin continuous infusion24 hours continuous infusion |
| Vancomycin with intermittent dose interval | Active comparator | Drug: Vancomycin intermittent dosing intervalinfusion rate 1000mg/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with suspected infection
- Calculated creatinine clearance > 60ml/min
Key exclusion criteria (6 listed)
- Age < 18 years
- Allergic to vancomycin
- Calculated creatinine clearance < 60ml/min
- Pregnant
- Vancomycin administration more than 8 hour and less than 24 hour prior to study enrollment
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 |
|---|---|---|
| Vancomycin continuous infusionVancomycin 24 hour intravenous continuous infusion | Drug | Vancomycin with continuous infusion |
| Vancomycin intermittent dosing intervalVancomycin intravenous infusion at rate 1000mg/hr | Drug | Vancomycin with intermittent dose interval |
Primary outcome
Number of Participants Who Achieved the Target Vancomycin Concentration
Time frame: 24 hours
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
2 secondary outcomes
Time Required to Reach the Therapeutic Levels
Time frame: as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)
Vancomycin Concentration at 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Hsin Lin, PharmD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin continuous infusion and Vancomycin intermittent dosing interval in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection, run by Massachusetts General Hospital 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 2 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: stopped early, as of the sponsor's last update on 7 Jun 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Achieved the Target Vancomycin Concentration (time frame: 24 hours). 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 7 Jun 2017.