None listed
Conditions
Brief summary
Antibiotics are crucial in the fight against serious infections. There is increasing resistance of bacteria to old antibiotics and new antibiotics are not readily being released for use. To fight antibiotic resistance, we need to use older antibiotics more effectively. To do this we need to study them more intensively in our sickest patients. Microsampling is a general technique for reducing blood collection volumes. It is not readily used in bedside practise. It is not well researched in clinical practise. The researchers aim to study antibiotics in children admitted to the intensive care unit at Lady Cilento Children’s Hospital that are receiving commonly prescribed antibiotics. They aim to study the blood levels to build up a picture of the effectiveness of current dosing regimens. This will be done with a combination of standard blood volume sampling (0.5mls -2mls) and micro blood sampling (~0.02ml). This will assess weather micro sampling is able to be utilised in this way and give meaningful results. Similar pilot studies have been undertaken in adults and it seems this is possible. The overall aim is to improve the understanding of antibiotic therapy in sick children and make future studies easier.
Interventions
Microsamples will be taken immediately prior to infusion of the antibiotic being studied (T0). Then again at 30mins post infusion (T1). Three other samples will be taken at regular intervals over the remaining time prior to the next dose. The interval of these samples is dependant on the dosing interval. At least two samples T0 and T1 will have a matched macro-sample. Ideally all micro-samples will have matched macro samples. This may not be achievable in all children. Micro samples consist of 1
Microsamples will be taken immediately prior to infusion of the antibiotic being studied (T0). Then again at 30mins post infusion (T1). Three other samples will be taken at regular intervals over the remaining time prior to the next dose. The interval of these samples is dependant on the dosing interval. At least two samples T0 and T1 will have a matched macro-sample. Ideally all micro-samples will have matched macro samples. This may not be achievable in all children. Micro samples consist of 10-20ul of capillary whole blood from a skin lancing. Macro samples consist of at least 100ul whole blood from a venous or arterial cannula. Sampling will be undertaken directly by research nurses or directly supervised by research nurses. Time of administration of antibiotics and sampling times will be accurately recorded. For the purposes of the study this will be recorded separately the medical record will not be assumed to be correct. This way the researchers aim to eliminate medication administration and sample timing as a source of error.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
Patients admitted to the Intensive Care Unit at the Lady Cilento Children’s Hospital Written or Phone consent informed consent has been obtained from the parent or guardian. Phone consent must be followed up by written consent. Receiving intravenous Piperacillin/Tazobactam, Vancomycin, Cefotaxime, Cefazolin, Meropenem, Ceftazidime and Flucloxacillin. Patients may receive multiple antibiotics concurrently.
Exclusion criteria
Known hypersensitivity to Piperacillin/Tazobactam, Vancomycin, Cefotaxime, Cefazolin, Meropenem , Ceftazidime or Flucloxacillin. Hb<80 g/L Recent (<24hrs) massive transfusion (>60mls/kg blood products) No arterial or venous access. Peripheral capillary shutdown with capillary refill time > 4 seconds. No capillary sampling sites (for example burns patients). Recent Cardiopulmonary Bypass Extracorporeal Renal, Cardiac or Respiratory support. Peritoneal Dialysis Approval by responsible Paediatric Intensivist not given
Outcome results
None listed