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AN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS

AN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21190
Enrollment
200
Registered
2015-12-07
Start date
2016-01-01
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

ICU, intensive care, TDM, therapeutic drug monitoring, beta-lactams, anitbiotics, cephalosporins, fluroquinolones, MIC, PK/PD, pharmacokinetcs, pharmacodynamics

Interventions

There is no intervention in this study that may affect patient treatment.

Sponsors

Erasmus University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Written informed consent has been obtained from the patient or their legally authorized representative. - Receiving intravenous antibiotic therapy of the target drugs. - Suitable intravenous/intra-arterial access to facilitate sample collection. - Treatment should be aimed for at least at 3 days. - Bacterial isolates sample are obtainable before start of the target drugs.

Exclusion criteria

Exclusion criteria: - Consent not obtained. - <18 years of age. - Antibiotic cessation within 72h of identification of expected sampling. - Medium care and burn wound patients admitted to the ICU.

Design outcomes

Primary

MeasureTime frame
to document whether empirical antibiotic dosing regimens of these antibiotics achieve defined therapeutic target concentrations in ICU patients.: Achievement of the PK/PD targets. PK/PD indices are calculated for each individual patient.

Secondary

MeasureTime frame
Comparison of observed PK/PD indices of the individual antibiotics with the length of ICU stay and sickness severity scores in ICU patients.

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)