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Development and validation of a pharmacokinetic model of flucloxacillin for dosing in patients with impaired renal function

Development and validation of a pharmacokinetic model of flucloxacillin for dosing in patients with impaired renal function - PK-model Flucloxacillin

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41120
Enrollment
80
Registered
2014-06-05
Start date
2015-01-07
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

Nierfunctiestoornissen impaired renal function

Interventions

None listed

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - adults treated with oral or intravenous flucloxacillin - normal and impaired renal function expressed as MDRD and corrected for BSA (body surface area)

Exclusion criteria

Exclusion criteria: - patients younger than 18 years of age; - legally incapable patients; - contra-indication or allergy to the treatment with flucloxacillin; - pregnant patients; - patients receiving dialysis.

Design outcomes

Primary

MeasureTime frame
Main study endpoint is the development of a PK-model for dosing of flucloxacillin in patients with impaired renal function.

Secondary

MeasureTime frame
Secondary endpoint is the predictive value of the model for dosing of flucloxacillin in patients with impaired renal function.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)