Right Dose, Right Now

Right Dose, Right Now: Randomized Clinical Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002478-37-NL

Enrollment

420

Registered

2017-11-06

Start date

2018-01-11

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious disease, sepsis

Interventions

Trade Name: Vancomycine Xellia Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VANCOMYCIN CAS Number: 1404-90-6 Trade Name: Ciprofloxacine Kabi Pharmaceutical Form: Solutio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >18 years - Suspected or confirmed infection - Suspected or confirmed lactate concentration > 2 mM - Treatment or imminent treatment with vasopressors - Treatment or imminent treatment with one or more of the following antibiotics: vancomycin, ceftriaxone, meropenem, ciprofloxacine, cefotaxime. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the influence of dosing guided by AutoK on achieving PK targets and clinical end points in intensive care patients with sepsis. ;Secondary Objective: Not applicable;Primary end point(s): PK target attainment in the first 24-hours. Targets are 100%-fT>4MIC for the beta-lactam antibiotics, fAUC/ MIC>400 for vancomycin and fAUC/MIC =125 for ciprofloxacin.;Timepoint(s) of evaluation of this end point: The first 24 hours after inclusion.	—

Measure

Time frame

Main Objective: The primary objective is to assess the influence of dosing guided by AutoK on achieving PK targets and clinical end points in intensive care patients with sepsis. ;Secondary Objective: Not applicable;Primary end point(s): PK target attainment in the first 24-hours. Targets are 100%-fT>4MIC for the beta-lactam antibiotics, fAUC/ MIC>400 for vancomycin and fAUC/MIC =125 for ciprofloxacin.;Timepoint(s) of evaluation of this end point: The first 24 hours after inclusion.

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Secondary

Measure	Time frame
Secondary end point(s): Time to PK target level, PK target attainment during therapy, attainment of clinical cure, length of ICU and hospital stay, delta SOFA score at 96 hours, days free of ventilator / hemofiltration / other organ support, ICU / hospital / 28 day / 6-month mortality, quality of life at hospital discharge (EQ-5D-5L) and after 6 months, societal costs (iMTA MCQ and iMTA PCQ at hospital discharge and after 6 months), days free of delirium. ;Timepoint(s) of evaluation of this end point: Please see E.5.2	—

Measure

Time frame

Secondary end point(s): Time to PK target level, PK target attainment during therapy, attainment of clinical cure, length of ICU and hospital stay, delta SOFA score at 96 hours, days free of ventilator / hemofiltration / other organ support, ICU / hospital / 28 day / 6-month mortality, quality of life at hospital discharge (EQ-5D-5L) and after 6 months, societal costs (iMTA MCQ and iMTA PCQ at hospital discharge and after 6 months), days free of delirium. ;Timepoint(s) of evaluation of this end point: Please see E.5.2

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Countries

Netherlands

Contacts

Public ContactProject leader

VU University Medical Center

p.elbers@vumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026