Gram-Positive Bacterial InfectionsNCT03560440
Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
An observational study of Gram-Positive Bacterial Infections, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Plasma exposure vancomycin
- How many people
- 368 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2014to Jun 2017
- 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: Pediatric patients treated with vancomycin and hospitalized in UZ Leuven between January 2012 and April 2014
Who may be able to join
- Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.
Read the detailed description
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine. Patient files will be screened for relevant information. Individual patients can be included multiple times if vancomycin has been administered more than once.
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Plasma exposure vancomycin
- Keywords
- Vancomycin, Pharmacokinetics, Trough level, Pediatric
- Medical subject headings
- Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exposure vancomycinOther
Investigation of plasma exposure of vancomycin.
| Study group | Role | What they receive |
|---|---|---|
| Plasma exposure vancomycin | Pediatric patients treated with vancomycin Receives: Other: Plasma exposure vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loading dose related plasma exposure vancomycin
Plasma exposure to vancomycin in relation to administered dose
Measured: 24 hours after loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study startJun 2014
- Primary completionFeb 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gram-Positive Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Retrospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Spriet, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Isabel Spriet, PharmD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560440
- Sponsor's protocol ID
- S56779
- Status last verified
- Jun 2018
- First submitted
- 29 Nov 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877.
PubMed 19569969Piro CC, Crossno CL, Collier A, Ho R, Koyama T, Frangoul H. Initial vancomycin dosing in pediatric oncology and stem cell transplant patients. J Pediatr Hematol Oncol. 2009 Jan;31(1):3-7. doi: 10.1097/MPH.0b013e31818b3520.
PubMed 19125078Glover ML, Cole E, Wolfsdorf J. Vancomycin dosage requirements among pediatric intensive care unit patients with normal renal function. J Crit Care. 2000 Mar;15(1):1-4. doi: 10.1053/jcrc.2000.0150001.
PubMed 10757191Kim DI, Im MS, Choi JH, Lee J, Choi EH, Lee HJ. Therapeutic monitoring of vancomycin according to initial dosing regimen in pediatric patients. Korean J Pediatr. 2010 Dec;53(12):1000-5. doi: 10.3345/kjp.2010.53.12.1000. Epub 2010 Dec 31.
PubMed 21253314Ito H, Shime N, Kosaka T. Pharmacokinetics of glycopeptide antibiotics in children. J Infect Chemother. 2013 Apr;19(2):352-5. doi: 10.1007/s10156-012-0458-8. Epub 2012 Aug 8.
PubMed 22872188
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03560440
- Acronym / sponsor ID
- S56779
- Conditions
- Gram-Positive Bacterial Infections
- Keywords
- Vancomycin, Pharmacokinetics, Trough level, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.
Detailed description
In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine. Patient files will be screened for relevant information. Individual patients can be included multiple times if vancomycin has been administered more than once.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma exposure vancomycin | – | Other: Plasma exposure vancomycinPediatric patients treated with vancomycin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients treated with vancomycin and hospitalized in UZ Leuven between January 2012 and April 2014
Key inclusion criteria (1 listed)
- Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Plasma exposure vancomycinInvestigation of plasma exposure of vancomycin. | Other | Plasma exposure vancomycin |
Primary outcome
Loading dose related plasma exposure vancomycin
Time frame: 24 hours after loading dose
Plasma exposure to vancomycin in relation to administered dose
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 18 Jun 2018.
- Background: PubMed 19569969Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877.
- Background: PubMed 19125078Piro CC, Crossno CL, Collier A, Ho R, Koyama T, Frangoul H. Initial vancomycin dosing in pediatric oncology and stem cell transplant patients. J Pediatr Hematol Oncol. 2009 Jan;31(1):3-7. doi: 10.1097/MPH.0b013e31818b3520.
- Background: PubMed 10757191Glover ML, Cole E, Wolfsdorf J. Vancomycin dosage requirements among pediatric intensive care unit patients with normal renal function. J Crit Care. 2000 Mar;15(1):1-4. doi: 10.1053/jcrc.2000.0150001.
- Background: PubMed 21253314Kim DI, Im MS, Choi JH, Lee J, Choi EH, Lee HJ. Therapeutic monitoring of vancomycin according to initial dosing regimen in pediatric patients. Korean J Pediatr. 2010 Dec;53(12):1000-5. doi: 10.3345/kjp.2010.53.12.1000. Epub 2010 Dec 31.
- Background: PubMed 22872188Ito H, Shime N, Kosaka T. Pharmacokinetics of glycopeptide antibiotics in children. J Infect Chemother. 2013 Apr;19(2):352-5. doi: 10.1007/s10156-012-0458-8. Epub 2012 Aug 8.
- Individual participant dataSharing planned: No
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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.
Isabel Spriet, PharmD PhD principal investigator
UZ Leuven
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 Gram-Positive Bacterial Infections, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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 18 Jun 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 Belgium. 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?
Loading dose related plasma exposure vancomycin (time frame: 24 hours after loading dose). 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 NCT03560440, which also lists 5 linked publications.
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 18 Jun 2018.