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Antibiotikapenetration og vævsrespons ved infektion og rekonstruktiv kirurgi i hoved-hals regionen

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526995-22-00
Enrollment
16
Registered
2026-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-02

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

Conditions

Treatment and prevention of post operative infections

Brief summary

T>MIC for all investigated antibiotics in the measured tissues and in plasma, calculated based on concentration–time profiles obtained from microdialysate samples and serial blood sampling. T>MIC will be calculated using predefined MIC target values for each IMP in the primary analysis: cefuroxime 4 mg/L, cloxacillin 2 mg/L, dicloxacillin 2 mg/L, and amoxicillin/clavulanic acid 2 mg/L, expressed as the amoxicillin component.

Detailed description

Pharmacokinetic parameters (Cmax, AUC, Tmax and T½) in tissue and plasma, Concentrations of glucose, lactate, pyruvate and glycerol, as well as inflammatory proteins, in microdialysate samples

Interventions

DRUGAMOXICILLIN
DRUGCEFUROXIME

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
T>MIC for all investigated antibiotics in the measured tissues and in plasma, calculated based on concentration–time profiles obtained from microdialysate samples and serial blood sampling. T>MIC will be calculated using predefined MIC target values for each IMP in the primary analysis: cefuroxime 4 mg/L, cloxacillin 2 mg/L, dicloxacillin 2 mg/L, and amoxicillin/clavulanic acid 2 mg/L, expressed as the amoxicillin component.

Secondary

MeasureTime frame
Pharmacokinetic parameters (Cmax, AUC, Tmax and T½) in tissue and plasma, Concentrations of glucose, lactate, pyruvate and glycerol, as well as inflammatory proteins, in microdialysate samples

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 5, 2026