None listed
Conditions
Brief summary
There is a small, but emerging body of knowledge demonstrating the safety and efficacy of subcutaneous (SC) infusion of antibiotics. This practice, popularised in France has been successfully implemented at Fiona Stanley Hospital both for in-patients as well as with the Infectious Diseases Ambulatory Care (IDAC) service delivering ceftriaxone, ertapenem and teicoplanin by this route to select patients. In this prospective, single arm cross over study, we aim to extend this experience to SC meropenem and cefazolin which are 2 commonly used antibiotics for severe infections in hospitalised patients. Patients already receiving either meropenem or cefazolin (usually given three times daily) will be followed closely following administration of IV dosing, followed by the same dose administered as a SC infusion. Detailed safety and tolerability assessments will be accompanied by collection of blood to measure antibiotic concentrations to confirm antibiotic exposure is not compromised.
Interventions
Cross-over, self-controlled trial. Pharmacokinetic data will be collected for both subcutaneous and intravenous administration for each participant.
For patients already receiving meropenem (1g dose) or cefazolin (2g dose) as part of their infection management plan (either once, twice or 3 times daily), the intervention is delivering one dose of the patient’s prescribed antibiotic via a subcutaneous catheter rather than the intravenous route.
The antibiotic will be administered intravenously
Cross-over, self-controlled trial. Pharmacokinetic data will be collected for both subcutaneous and intravenous administration for each participant. For patients already receiving meropenem (1g dose) or cefazolin (2g dose) as part of their infection management plan (either once, twice or 3 times daily), the intervention is delivering one dose of the patient’s prescribed antibiotic via a subcutaneous catheter rather than the intravenous route. The antibiotic will be administered intravenously in accordance with packaging and local guidelines. A venous blood sample (3mLs of blood in a lithium heparin tube) will be collected immediately prior to infusion (T0), then 0.5, 1, 2, 4, and 8 hours post-initiation of infusion for patients on three times daily (i.e. 8 hourly) dosing regimens, with additional samples at 12 hours for patients on twice daily (i.e. 12 hourly) dosing, and at 18 and 24 hours for patients on daily dosing. The patient’s next dose will be administered via the subcutaneous route, according to the following: - The charted dose of antibiotic will be prepared to a 50mL volume with normal saline - A flexible subcutaneous needle will be inserted - The dose will be delivered over 30 minutes via gravity feed. - The needle will be removed after the dose is delivered Venous blood samples will be taken at the same time points as for the IV dose (T0, then 0.5, 1, 2, 4 and 8 hours post initiation of infusion in patients on three times daily (i.e. 8 hourly) dosing regimens, with additional samples at 12 hours for patients on twice daily (i.e. 12 hourly) dosing, and at 18 and 24 hours for patients on daily dosing. After the single subcutaneous dose, patients will revert to the intravenous route for their next scheduled dose.
Sponsors
Laurens Manning
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age or over. Inpatient who is clinically stable, defined as not having been in ICU or having had an emergency response call in the 24 hours prior to enrolment. Ability to provide informed consent. Patient must be receiving = 1g of meropenem or = 2g cefazolin daily. Anticipated to require IV cefazolin or meropenem for at least 48 hours after enrolment.
Exclusion criteria
•Patients not clinically stable, as defined by being in ICU, having had a MET call in the 24 hours before screening for enrolment. •Children <18 years •Patients whose treating team predict will cease meropenem within 48 hours. •Patients receiving >1g meropenem, or >2g cefazolin per dosing interval. •Patients also taking medications predicted to interfere with meropenem or cefazolin pharmacokinetics (valproic acid, probenecid) •Patients unable to give informed consent themselves.
Outcome results
None listed