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An exploratory pharmacokinetic and pharmacodynamic study of beta-lactam and fluoroquinolone in ICU patients

An exploratory pharmacokinetic and pharmacodynamic study of beta-lactam and fluoroquinolone in ICU patients - EXPAT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43959
Enrollment
200
Registered
2015-10-20
Start date
2016-01-05
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Sepsis

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All the patients admitted to the ICU or internal medicine ward and given standard of care intravenous therapy of either one or both of the target antibiotic classes are included. Antibiotic initiation based on clinical suspicion of infection and/or cultured pathogens susceptible to the target drugs, initial dosage prescription, and duration of therapy are at the discretion of the attending physician. ;In order to be eligible to participate in this study, a subject must also meet all of the following 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. *

Design outcomes

Primary

MeasureTime frame
Achievement of the PK/PD targets: time that free (unbound) fraction of beta-lactam concentration remains above the MIC during a dosing interval (100%*T>MIC and 100%*T>4xMIC) and for the fluoroquinolone the Area Under the concentration-time Curve for the free (unbound) fraction of above the MIC (fAUC/MIC) ratio, maximum serum concentration (fCmax) and the fCmax/MIC ratio.

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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)