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ANTIMIDIS - Cefazolin mediastinal distribution using microdialysis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521988-13-00
Enrollment
10
Registered
2026-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-05

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

Conditions

Infection prophylaxis

Brief summary

Population pharmacokinetic parameters and inter-individual variability: distribution volume, total clearance, intercompartmental clearance (plasma to mediastinum)

Detailed description

Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) software, Data collected during the month following probe removal: Clinical progression: survival or death, post-operative mediastinitis, other bacterial infections, MIC of the bacteria if measured; Antibiotics received; Inflammation markers and progression: CRP.

Interventions

DRUGCEFAZOLIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Population pharmacokinetic parameters and inter-individual variability: distribution volume, total clearance, intercompartmental clearance (plasma to mediastinum)

Secondary

MeasureTime frame
Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) software, Data collected during the month following probe removal: Clinical progression: survival or death, post-operative mediastinitis, other bacterial infections, MIC of the bacteria if measured; Antibiotics received; Inflammation markers and progression: CRP.

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 6, 2026