Clinical Trial Results:
Impact of Model-Informed Precision Dosing of Vancomycin in Adults: A randomized, controlled clinical trial
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Summary
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EudraCT number |
2021-003670-31 |
Trial protocol |
BE |
Global end of trial date |
07 Nov 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
29 May 2026
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First version publication date |
29 May 2026
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Other versions |
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Summary report(s) |
Final Study Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BC-10433
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University Hospital Ghent
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Sponsor organisation address |
C. Heymanslaan 10, Gent, Belgium, 9000
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Public contact |
HIRUZ, Ghent University Hospital, +32 093320530, hiruz.ctu@uzgent.be
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Scientific contact |
HIRUZ, Ghent University Hospital, +32 093320530, hiruz.ctu@uzgent.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 May 2026
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Nov 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Nov 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This study will test the primary hypothesis that AUC/MIC based vancomycin dosing, using a model-informed precision dosing calculator, increases the proportion of patients reaching the therapeutic target AUC24u/MIC (400-600) between [48-72] h after start of treatment, when compared to the use of standard-of-care dosing regimens with therapeutic drug monitoring.
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Protection of trial subjects |
See attachment
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Dec 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 155
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Worldwide total number of subjects |
155
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EEA total number of subjects |
155
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
155
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
see attachment | |||||||||
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Pre-assignment
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Screening details |
see attachment | |||||||||
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Period 1
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Period 1 title |
Overal Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
see attachment
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Standard-of-care | |||||||||
Arm description |
See attachment | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Intervention | |||||||||
Arm description |
see attachment | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Vancomycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
see attachment
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End points reporting groups
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Reporting group title |
Standard-of-care
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Reporting group description |
See attachment | ||
Reporting group title |
Intervention
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Reporting group description |
see attachment | ||
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End point title |
Primary [1] | |||||||||
End point description |
Proportion of patients reaching target AUC24h/MIC (400-600) between 48h and 72h after start of vancomycin treatment
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attachment for more end points |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the study, see attachment
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: See attachment |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
