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Right Dose, Right Now: Randomized Controlled Clinical Trial

Right Dose, Right Now: Randomized Controlled Clinical Trial - Right Dose, Right Now: Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53354
Enrollment
420
Registered
2018-05-28
Start date
2018-02-19
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

blood poisoning infection infectious disease Sepsis

Interventions

Patients will be randomized to one of two groups. Group 1 (Control group): standard intravenous antibiotic therapy based on current clinical guidelines and practice. Standard therapy will include TD
Prediction
Antibiotics

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

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

Secondary

MeasureTime frame
Time to PK target level, PK target attainment during therapy, attainment of clinical cure, length of ICU and hospital stay, delta Sequential Organ Failure Assessment (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 after 6 months), days free of delirium. We will assess physician compliance and satisfaction with AutoK and investigate whether its use is associated with an increase in PK/PD knowledge amongst healthcare workers.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)