None listed
Conditions
Brief summary
This study is investigating whether antibiotics that are usually given through a vein can instead be given under the skin (subcutaneously) in children. Giving antibiotics under the skin (subcutaneously) may reduce the need for intravenous lines, reduce complications, and improve comfort. Participants will receive their prescribed antibiotic through both methods in a randomised order. Blood samples will be collected to assess antibiotic blood levels in the body with each method. The study will also assess safety, pain and acceptability of each method.
Interventions
Intervention: Subcutaneous (SC) administration of clinically indicated ceftriaxone, cefazolin, or meropenem, diluted in normal saline, administered via an indwelling subcutaneous catheter device.
A subcutaneous cannula will be inserted at an appropriate site (e.g. abdomen or thigh). Pre-procedural comfort measures as part of standard care, include the use of oral sucrose for infants and topical anaesthetic (e.g. EMLA cream in children older than 3 months of age), will be offered to each partici
Intervention: Subcutaneous (SC) administration of clinically indicated ceftriaxone, cefazolin, or meropenem, diluted in normal saline, administered via an indwelling subcutaneous catheter device. A subcutaneous cannula will be inserted at an appropriate site (e.g. abdomen or thigh). Pre-procedural comfort measures as part of standard care, include the use of oral sucrose for infants and topical anaesthetic (e.g. EMLA cream in children older than 3 months of age), will be offered to each participant prior to the procedures. An IV device may be left in situ whilst the SC treatment-route is completed to allow return to IV therapy and minimise procedures. Dose administered: max 2g / dose for each antibiotic Frequency: Ceftriaxone – 12 or 24-hourly. Cefazolin – 6 or 8 hourly. Meropenem – 8 hourly. Duration: 20 mL over 30 mins, followed by a 5 mL saline flush. Total duration: up to 48 hours Who will administer: Ward nursing staff Strategies to assess adherence to intervention: Participant compliance, including route and timing adherence, will be assessed using prescription medication records and source documentation, including infusion start and finish times. An acceptability rating survey for the parent/caregiver, child/adolescent and healthcare worker will also be performed. If the allocated route of administration cannot be continued (e.g. intolerance, device failure, adverse event, clinical deterioration), participants may switch early to the alternate route or routine care. Early treatment route switches are recorded with the reason documented. No pharmacological washout is required, given beta-lactams have short half-lives, comparison is within-subject and PK modelling accounts for time and dosing history. The alternate antibiotic administration route will be used for the next dose. Ceftriaxone, Cefazolin and Meropenem will be assessed and analysed separately. Participants will only receive one of the three antibiotics.
Sponsors
Child and Adolescent Health Service (Perth Children's Hospital)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 6570 Days
Healthy volunteers
No
Inclusion criteria
1. Aged below 18 years and weight of at least 3.5 kg. 2. Admitted to the hospital study site. 3. Prescribed ceftriaxone, cefazolin or meropenem as part of routine care, planned for more than 24 hours.
Exclusion criteria
1. Requirement for intensive care admission or medical emergency team (MET) call within the previous 24 hours. 2. Known severe hypersensitivity to ß-lactam antibiotics (e.g.anaphylaxis, severe cutaneous reaction). 3. Severe skin disease at proposed SC administration sites that would preclude safe infusion. 4. The primary treating clinician deems enrolment not in the best interests of the child.
Outcome results
None listed