Right Dose, Right Now: Randomized Controlled Clinical Trial

Completed

• Conditions: blood poisoning; infection; infectious disease; Sepsis; 10019815

• Registration Number: NL-OMON53354
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-02
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 252

Inclusion Criteria

- Age >18 years
- Suspected / confirmed infection
- Suspected / confirmed lactate concentration > 2 mM OR treatment / imminent treatment with vasopressors
- Treatment / imminent treatment with one or more of the following antibiotics: vancomycin, ceftriaxone, meropenem, ciprofloxacine, cefotaxime.

Exclusion Criteria

None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK target attainment in the first 24-hours. Targets are 100%-fT>4MIC for the<br /><br>beta-lactam antibiotics, AUC/ MIC>400 for vancomycin and fAUC/MIC *125 for<br /><br>ciprofloxacin.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to PK target level, PK target attainment during therapy, attainment of<br /><br>clinical cure, length of ICU and hospital stay, delta Sequential Organ Failure<br /><br>Assessment (SOFA) score at 96 hours, days free of ventilator / hemofiltration /<br /><br>other organ support, ICU / hospital / 28 day / 6-month mortality, quality of<br /><br>life at hospital discharge (EQ-5D-5L) and after 6 months, societal costs (iMTA<br /><br>MCQ and iMTA PCQ after 6 months), days free of delirium.<br /><br><br /><br>We will assess physician compliance and satisfaction with AutoK and investigate<br /><br>whether its use is associated with an increase in PK/PD knowledge amongst<br /><br>healthcare workers.</p><br>