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Dose individualization of Beta-lactam and fluoroquinolone antibiotics in ICU patients: to TDM or not to TDM and the effects on Outcome

Dose individualization of Beta-lactam and fluoroquinolone antibiotics in ICU patients: to TDM or not to TDM and the effects on Outcome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21680
Enrollment
250
Registered
2018-05-18
Start date
2018-09-01
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

Intensive care, Antibiotics, Pharmacodynamics, Pharmacokinetics

Interventions

Assigned interventions in the active TDM group: dosage of beta-lactam and fluoroquinolone antibiotics will be adjusted according to serum concentrations. In the non-TDM (control) group samples of seru

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - ≥18 years of age - Receiving intravenous antibiotic therapy of the target drugs - Treatment should be aimed for at least 2 days.

Exclusion criteria

Exclusion criteria: - Pregnancy - Patient already enrolled in this trial - Antibiotic cessation before sampling - Medium care and burn wound patients admitted to the ICU - Patients receiving cefotaxime as prophylaxis only within the context of Selective Digestive tract Decontamination (SDD)

Design outcomes

Primary

MeasureTime frame
Pharmacodynamic target attainment: - Beta-lactam: %ƒT>MIC(ECOFF) (including % of patients with 100%ƒT>MIC(ECOFF) in both groups). - Fluoroquinolone: ƒAUC/MIC(ECOFF) (including % of patients with ƒAUC/MIC(ECOFF)≥100 in both groups)

Secondary

MeasureTime frame
To determent if active TDM results in improved clinical outcome, increased cost-effectiveness, better quality of life and less post-ICU syndrome. - Clinical outcomes are 28-day mortality, SOFA (sequential organ failure assessment score, use of other antibiotics, readmittance and procalcitonin decrease. - Cost-effectiveness will be determined directly (costs of stay at ICU, including treatment costs) and using appropriate health – economic analysis.

Contacts

Public ContactA Abdulla

Erasmus Medical Centre - Department of Hospital Pharmacy

a.abdulla@erasmusmc.nl+31(0)10-7040704/+31(0)6-42119481

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)