None listed
Conditions
Brief summary
There is an increasing body of evidence demonstrating the safety and efficacy of subcutaneous (SC) administration of antibiotics. This is a prospective single arm cross over design study aims to extend our experience with subcutaneously administered antibiotics by determining the safety and tolerability of subcutaneous administration of 2g of ceftriaxone. Inpatients already receiving ceftriaxone 2g to treat an infection will have dry blood spots (DBS) collected immediately prior to an intravenous dose and at several time points subsequently over the dosing interval to measure the antibiotic concentrations in bloods. They will then have DBS collected at the same time points with a single dose of ceftriaxone 2g administered via subcutaneous infusion. Patients will be closely followed throughout the study with detailed safety and tolerability assessments completed. We hypothesise that the administration of 2g subcutaneous Ceftriaxone will be safe and well tolerated with equivalent bioavailability to intravenous administration of the same dose.
Interventions
For patients already receiving ceftriaxone 2g as part of their infection management plan the intervention is delivering one dose of the patient’s prescribed antibiotic via the subcutaneous (SC: intervention arm) rather than the intravenous (IV: control arm) route. Both the intravenous and subcutaneous doses will be administered by a registered nurse.
The antibiotic will be administered intravenously accordance with packaging and local guidelines. A dry blood spot blood sample will be collected
For patients already receiving ceftriaxone 2g as part of their infection management plan the intervention is delivering one dose of the patient’s prescribed antibiotic via the subcutaneous (SC: intervention arm) rather than the intravenous (IV: control arm) route. Both the intravenous and subcutaneous doses will be administered by a registered nurse. The antibiotic will be administered intravenously accordance with packaging and local guidelines. A dry blood spot blood sample will be collected immediately prior to infusion (T0), then 0.75-1, 2-3, 4-5, 8 hours (or as late as possible on the day) and 12 hours post-initiation (but before the next dose for those on twice daily dosing) of infusion for patients on twice daily dosing. For the majority of patients on once daily dosing regimens, an additional sample at 24 hours post initiation of infusion will be collected (which will also be the pre-dose sample timepoint for the SC administration. The patient’s next dose will be administered via the SC route, adopting the existing protocol for ertapenem, 1g ceftriaxone and teicoplanin: - The charted dose of antibiotic will be prepared to a 50mL volume with normal saline - A flexible subcutaneous needle (23G) will be inserted - The dose will be delivered over 30 minutes via gravity feed or infusion pump - The needle will be removed after the SC dose is delivered. - Dry blood spots will be collected at the same time points as for the IV dose (prior to the infusion (T0), then 0.75-1, 2-3, 4-5, 8 hours (or as late as possible on the day) and 12 hours post-initiation (but before the next dose) of infusion for patients on twice daily dosing. For patients on once daily dosing regimens, an additional sample at 24 hours post initiation of infusion will be collected. - After the single SC dose, patients will revert to the IV route for their next scheduled dose. Administration of antibiotics, and collection of dried blood samples will be documented in the patient's electronic medical records to ensure adherence.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Must meet all of: - Age 18 years and older. - Inpatient at Fiona Stanley Hospital - Capacity to provide informed consent. - Prescribed ceftriaxone 2g as part of their infection management plan.
Exclusion criteria
Patients will not be eligible for participation if any of the following criteria are met: - Patients deemed to be clinically unstable (defined as requiring High-level dependency care (HDU)/Intensive care (ICU) or having had a medical emergency team (MET) call within the preceding 24 hours) - Patients with a history of cognitive impairment, intellectual disability or a mental illness that leads to the inability to provide informed consent - Children < 18 years. - History of anaphylaxis or serious adverse reaction to cephalosporins in past.
Outcome results
None listed