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Trial registered on ANZCTR


Registration number
ACTRN12618001469202
Ethics application status
Approved
Date submitted
12/06/2018
Date registered
31/08/2018
Date last updated
31/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can blood microsampling improve doctors ability to dose antibiotics in children admitted to intensive care
Scientific title
An investigation of the utility of microsampling versus traditional blood sampling for antibiotic pharmacokinetics in children admitted to ICU
Secondary ID [1] 295183 0
None
Universal Trial Number (UTN)
U1111-1215-5510
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 308311 0
Paediatric Critical illness 308313 0
Condition category
Condition code
Infection 307313 307313 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312231 0
Treatment: Devices
Comparator / control treatment
The traditional macro-sample will be a comparator group. The microsample group will be compared to this for accuracy of sampling. Both samples (and their data ) will be used in the Pharmacokinetic analysis of the antibiotics.
Control group
Active

Outcomes
Primary outcome [1] 306271 0
Results will be used to develop a pharmacological model. Using computer modelling and pharmacokinetic analysis of the administered antibiotic regimes the investigators will assess if adequate antibiotic exposure is achieved. Effectiveness of therapy will be determined by percentage of target attainment (%PTA). For betalactams antibiotics this is be the percentage of time greater than MIC. ( %T>MIC ). For Vancomycin this will be the percentage time the AUC:MIC ratio is greater than 400.
Timepoint [1] 306271 0
Time points of sample collections will vary depending on the antibiotic dosing interval. Samples will be collected just prior and following the antibiotic administration. Thereafter a further 3 samples will be collected. These vary and are specified in the protocol.
Secondary outcome [1] 351354 0
Reliability of Micro versus Macro sampling.
Samples will be taken in pairs on at least two time points. Time point zero. Just prior to the administration of the antibiotic. An antibiotic trough level. Time point T30 is 30mins post infusion. This will be a peak antibiotic level. There will be other matched time points depending on the availability of sampling. These two time points will be used to validate micro sampling as an effective way to sample less invasively for pharmacokinetic studies. Microsampling is not yet generally accepted for human pharmacokinetic studies. This data will add to the body of knowledge and advance understanding of its potential research and clinical use. Research of its utility will advance paediatric pharmacokinetic research.
Timepoint [1] 351354 0
Time point 0 mins and 30mins. Some subjects will be sampled in pairs at other times depending on availability of sampling.

Eligibility
Key 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.
Minimum age
1 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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


Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Pharmacokinetic analysis to assess adequacy of antibiotic exposure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2018
Actual
Date of last participant enrolment
Anticipated
1/09/2019
Actual
Date of last data collection
Anticipated
1/09/2019
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11129 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 22945 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 299768 0
Charities/Societies/Foundations
Name [1] 299768 0
Children's Hospital Foundation. (Brisbane)
Country [1] 299768 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland
St Lucia
Brisbane
QLD 4072
Australia
Country
Australia
Secondary sponsor category [1] 299111 0
Hospital
Name [1] 299111 0
Lady Cilento Children's Hospital
Address [1] 299111 0
501 Stanley Street
South Brisbane
Queensland 4101
Country [1] 299111 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300659 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 300659 0
Ethics committee country [1] 300659 0
Australia
Date submitted for ethics approval [1] 300659 0
29/05/2017
Approval date [1] 300659 0
01/11/2017
Ethics approval number [1] 300659 0
2017001499

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84374 0
Dr Tavey Dorofaeff
Address 84374 0
c/o Paediatric Intensive Care Unit
Lady Cilento Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 84374 0
Australia
Phone 84374 0
+61730682399
Fax 84374 0
+61730681499
Email 84374 0
tavey.dorofaeff@health.qld.gov.au
Contact person for public queries
Name 84375 0
Tavey Dorofaeff
Address 84375 0
c/o Paediatric Intensive Care Unit
Lady Cilento Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 84375 0
Australia
Phone 84375 0
+61730682399
Fax 84375 0
+61730681499
Email 84375 0
tavey.dorofaeff@health.qld.gov.au
Contact person for scientific queries
Name 84376 0
Tavey Dorofaeff
Address 84376 0
c/o Paediatric Intensive Care Unit
Lady Cilento Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 84376 0
Australia
Phone 84376 0
+61730682399
Fax 84376 0
+61730681499
Email 84376 0
tavey.dorofaeff@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4707Study results articleYes Parker SL, Wallis SC, Fourie C, Lassig-Smith M, St... [More Details]
4708Study results articleYes Parker SL, Wallis SC, Fourie C, Lassig-Smith M, St... [More Details]
4709Study results articleYes Guerra Valero YC, Dorofaeff T, Coulthard MG, Spark... [More Details]
4710Study results articleYes Guerra Valero YC, Dorofaeff T, Roberts JA, Lipman ... [More Details]
4711Study results articleYes Oliveira RV, Chalom MY, Kiffer CR. Collection and ... [More Details]

Documents added automatically
No additional documents have been identified.