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Updated: Oct 7, 2026
A Novel Method to Determine the Longitudinal Antibacterial Activity of Drug-Eluting Materials
Published on: March 3, 2023
Pharmacokinetic longitudinal studies of antibiotics administered via a permanent intraosseous device in micropigs
P Chastagner1, A Lozniewski, P Lascombes
1Department of Pediatric Oncology, University Hospital, Nancy, France. p.chastagner@chu-nancy.fr
Background:
In critically ill children, intraosseous (IO) administration of a medicine provides an alternate vascular access route when IV access is not readily available. We investigated the short and long-term efficacy and safety of a totally intraosseously implantable device.
Procedure:
This study was undertaken in micropigs (i) to compare serum levels achieved by equal bolus dosages of two antibiotics (amikacin and vancomycin) administered through an intratibial needle, an intraosseous implantable device and central IV routes to determine whether standard parenteral dosing guidelines for antibiotics may be applied without modification for IO injection, and (ii) to show the efficiency of the implantable device over a prolonged period, as a permanent access to intraosseous space.
Results:
The area under the plasma concentration time curves were similar for IV, intratibial and through the intraosseous implantable device, for intermittent administrations of amikacin and vancomycin, over a period of 6 months. However, vancomycin did not reach therapeutic levels via both IO routes. We did not find any alteration of amikacin and vancomycin pharmacokinetics over a period of 6 months using the implantable device. No complication occurred.
Conclusions:
Long-term administration of antibiotics through a totally implantable intraosseous device is feasible and safe in micropigs. Although the procedure seems promising, additional studies of the continuous infusion of chemotherapeutic agents, blood products and antimicrobial solutions are needed prior to use in humans.
Insights
A totally implantable intraosseous device is safe for long-term antibiotic delivery in pigs. This novel vascular access method shows promise, but further research is needed before human application.
Area of Science:
- Pharmacology
- Medical Devices
- Pediatric Critical Care
Background:
- Intraosseous (IO) drug administration offers an alternative vascular access route in critically ill children when intravenous (IV) access is challenging.
- This study evaluated the efficacy and safety of a novel, totally implantable intraosseous device for drug delivery.
Purpose of the Study:
- To compare serum antibiotic levels from intratibial needle, implantable intraosseous device, and central IV routes.
- To assess if standard antibiotic dosing guidelines are applicable for intraosseous administration.
- To demonstrate the long-term functionality of the implantable device for sustained intraosseous access.
Main Methods:
- Micropigs were used to compare serum concentrations of amikacin and vancomycin via intratibial needle, implantable IO device, and central IV routes.
- Pharmacokinetic profiles were monitored over 6 months to assess drug levels and device efficiency.
- Safety and complications were evaluated throughout the study period.
Main Results:
- Area under the plasma concentration-time curves were comparable across IV, intratibial, and implantable IO device routes for intermittent amikacin and vancomycin administration over 6 months.
- Vancomycin did not achieve therapeutic levels via either IO route.
- No alterations in amikacin or vancomycin pharmacokinetics were observed with the implantable device over 6 months, with no complications reported.
Conclusions:
- Long-term antibiotic administration via a totally implantable intraosseous device is feasible and safe in a porcine model.
- The implantable IO device shows potential for sustained drug delivery.
- Further investigation into continuous infusion of various agents (chemotherapeutics, blood products, antimicrobials) is warranted before human trials.
