Bacterial InfectionsNCT01932034
Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software
An observational study of Bacterial Infections, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
We will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. We will also include therapeutic outcomes and costs in the analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- BestDose Computer Software
- Type of treatment
- Medical device
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 4 Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment
Who may be able to join
- Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment.
- Participants will of any age.
- Participant/parent/legal guardian (as applicable) must be able and willing to provide signed informed consent.
Who cannot join
- Prior receipt of vancomycin for the same clinical event (e.g. the same fever of unknown origin in a neutropenic patient defined as <24 hours of no fever)
- Known colonization or infection with a vancomycin resistant organism (MIC > 2 mg/L)
- Known hypersensitivity or intolerance to vancomycin
- Patients on any form of dialysis
- Not expected to survive >72 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County - University of Southern California Medical Center
Los Angeles, California, 90033
About this study
Official title: Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Multiple-Model Bayesian Adaptive Control
We will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. We will also include therapeutic outcomes and costs in the analysis.
Read the detailed description
Recent guidelines to use the antibiotic vancomycin for serious, resistant gram-positive bacterial infections advocate higher plasma concentrations than are routinely achieved with conventional dosing. Moreover, there is wide interpatient variability in vancomycin plasma concentrations, even with standardized dosing. The hypothesis for this study is that dosing vancomycin assisted by computer software and Bayesian algorithms will lead to more rapid and accurate attainment of therapeutic blood vancomycin concentrations in children and adults. This study will enroll 90 patients per year for three years, totaling 270 patients. Eligible patients will be of any age and who are to be prescribed vancomycin by their clinicians for medical indications. Patients with vancomycin-resistant organisms, severe vancomycin allergies or who need dialysis will not be eligible. Participants in the first group of 90 will be treated according to standard care. The second and third groups of patients will be dosed with vancomycin according to the recommendations made by the study team using the BestDose software developed by the USC Laboratory of Applied Pharmacokinetics. The second group will be dosed with the software in its current form, and the third group with funded updates. For all groups, no additional blood samples will be drawn for research purposes; only routinely obtained clinical data will be used. The primary outcome in all groups will be the percentage of participants with appropriate vancomycin concentrations. Secondary outcomes in those who receive vancomycin for at least 72 hours will include effectiveness, toxicity rates, and costs of therapy. Participation in the study will cease at the time of hospital discharge or 72 hours after termination of vancomycin therapy.
- Conditions
- Bacterial Infections
- Being tested
- BestDose Computer Software
- Keywords
- Vancomycin, Pharmacokinetics, Pharmacodynamics, Decision support
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BestDose Computer SoftwareDevice
BestDose is made by the USC Laboratory of Applied Pharmacokinetics. It uses a multiple-model, Bayesian adaptive control algorithm to find the maximally precise dose that will achieve a user-specified target concentration or concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Standard dosing | Vancomycin dosed and monitored according to standard practice | |
| BestDose Computer Software | Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations Receives: Device: BestDose Computer Software | |
| BestDose Computer Software 2 | Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations and with computer-generated suggested optimal blood sampling times Receives: Device: BestDose Computer Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to therapeutic vancomycin blood concentration
Measured: Within first week of dosing
Secondary outcomes (2)
Number of blood samples sent for vancomycin concentration measurement
Measured: Duration of therapy, an average of 10 days in the hospital
Incidence of nephrotoxicity
Defined as >0.5 mg/dL or >50% rise from baseline serum creatinine
Measured: Duration of therapy, an average of 10 days in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startSep 2012
- Primary completion1 Jul 2016
- Study completion4 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Michael Neely, Children's Hospital Los Angeles
- Investigators
- Michael Neely, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932034
- Sponsor's protocol ID
- LACUSC-Van-01
- Other IDs
- R01GM068968
- Status last verified
- Feb 2018
- First submitted
- 6 Aug 2013
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Individual data requests will be evaluated on a case-by-case basis.
Publications
Neely MN, Kato L, Youn G, Kraler L, Bayard D, van Guilder M, Schumitzky A, Yamada W, Jones B, Minejima E. Prospective Trial on the Use of Trough Concentration versus Area under the Curve To Determine Therapeutic Vancomycin Dosing. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e02042-17. doi: 10.1128/AAC.02042-17. Print 2018 Feb.
PubMed 29203493
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Multiple-Model Bayesian Adaptive Control
- ClinicalTrials.gov ID
- NCT01932034
- Acronym / sponsor ID
- LACUSC-Van-01
- Conditions
- Bacterial Infections
- Keywords
- Vancomycin, Pharmacokinetics, Pharmacodynamics, Decision support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Sep 2012 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 4 Jul 2016 (actual)
- First posted
- 30 Aug 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.
We will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. We will also include therapeutic outcomes and costs in the analysis.
Detailed description
Recent guidelines to use the antibiotic vancomycin for serious, resistant gram-positive bacterial infections advocate higher plasma concentrations than are routinely achieved with conventional dosing. Moreover, there is wide interpatient variability in vancomycin plasma concentrations, even with standardized dosing. The hypothesis for this study is that dosing vancomycin assisted by computer software and Bayesian algorithms will lead to more rapid and accurate attainment of therapeutic blood vancomycin concentrations in children and adults. This study will enroll 90 patients per year for three years, totaling 270 patients. Eligible patients will be of any age and who are to be prescribed vancomycin by their clinicians for medical indications. Patients with vancomycin-resistant organisms, severe vancomycin allergies or who need dialysis will not be eligible. Participants in the first group of 90 will be treated according to standard care. The second and third groups of patients will be dosed with vancomycin according to the recommendations made by the study team using the BestDose software developed by the USC Laboratory of Applied Pharmacokinetics. The second group will be dosed with the software in its current form, and the third group with funded updates. For all groups, no additional blood samples will be drawn for research purposes; only routinely obtained clinical data will be used. The primary outcome in all groups will be the percentage of participants with appropriate vancomycin concentrations. Secondary outcomes in those who receive vancomycin for at least 72 hours will include effectiveness, toxicity rates, and costs of therapy. Participation in the study will cease at the time of hospital discharge or 72 hours after termination of vancomycin therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dosing | – | –Vancomycin dosed and monitored according to standard practice |
| BestDose Computer Software | – | Device: BestDose Computer SoftwareVancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations |
| BestDose Computer Software 2 | – | Device: BestDose Computer SoftwareVancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations and with computer-generated suggested optimal blood sampling times |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment
Key inclusion criteria (3 listed)
- Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment.
- Participants will of any age.
- Participant/parent/legal guardian (as applicable) must be able and willing to provide signed informed consent.
Key exclusion criteria (5 listed)
- Prior receipt of vancomycin for the same clinical event (e.g. the same fever of unknown origin in a neutropenic patient defined as <24 hours of no fever)
- Known colonization or infection with a vancomycin resistant organism (MIC > 2 mg/L)
- Known hypersensitivity or intolerance to vancomycin
- Patients on any form of dialysis
- Not expected to survive >72 hours.
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 |
|---|---|---|
| BestDose Computer SoftwareBestDose is made by the USC Laboratory of Applied Pharmacokinetics. It uses a multiple-model, Bayesian adaptive control algorithm to find the maximally precise dose that will achieve a user-specified target concentration or concentrations. | Device | BestDose Computer Software, BestDose Computer Software 2 |
Primary outcome
Time to therapeutic vancomycin blood concentration
Time frame: Within first week of dosing
2 secondary outcomes
Number of blood samples sent for vancomycin concentration measurement
Time frame: Duration of therapy, an average of 10 days in the hospital
Incidence of nephrotoxicity
Time frame: Duration of therapy, an average of 10 days in the hospital
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 20 Feb 2018.
- Derived from this study: PubMed 29203493Neely MN, Kato L, Youn G, Kraler L, Bayard D, van Guilder M, Schumitzky A, Yamada W, Jones B, Minejima E. Prospective Trial on the Use of Trough Concentration versus Area under the Curve To Determine Therapeutic Vancomycin Dosing. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e02042-17. doi: 10.1128/AAC.02042-17. Print 2018 Feb.
- Individual participant dataSharing planned: Undecided. Individual data requests will be evaluated on a case-by-case basis.
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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.
Michael Neely, MD principal investigator
Children's Hospital Los Angeles
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 Bacterial Infections, run by Children's Hospital Los Angeles 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 3 inclusion and 5 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 20 Feb 2018. 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 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?
Time to therapeutic vancomycin blood concentration (time frame: Within first week of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932034, which also lists 1 linked publication.
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 20 Feb 2018.