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Trial registered on ANZCTR
Registration number
ACTRN12625000384459
Ethics application status
Approved
Date submitted
17/02/2025
Date registered
30/04/2025
Date last updated
30/04/2025
Date data sharing statement initially provided
30/04/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
An assessment of the safety, efficacy and patient satisfaction of Intravenous antibiotics administered at home as a continuous infusion through a peripheral intravenous cannula, by 4 Australian Hospital in the Home (HITH) services
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Scientific title
Continuous intravenous antibiotic infusion administered via a peripheral intravenous cannula in the Hospital in the Home (HITH) setting
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Secondary ID [1]
313894
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None
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Universal Trial Number (UTN)
U1111-1318-7901
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
infections requiring intravenous antibiotic treatment
336576
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Condition category
Condition code
Infection
333086
333086
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0
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Studies of infection and infectious agents
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Public Health
333087
333087
0
0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This will be a multicentre (4 Australian Hospital in the Home (HITH) services) prospective cohort study where the patient population will be HITH patients prescribed short term (<2 weeks) continuous antibiotics as an infusion via a Peripheral Intravenous Cannula (PIVC).
The practice of providing a continuous antibiotic infusion via a PIVC at home is something that has been occurring at all 4 sites for a number of years and will be offered to all suitable patients (as per study protocol) with a diagnosis and clinical scenario in whom IV antibiotics are indicated and where the antibiotic is suitable to be provided as a continuous infusion (dependent on antibiotic stability as an infusion and low risk of peripheral venous irritation) - this is regardless of whether they consent to study participation or not. It is already standard practice at all 4 sites (and many other HITH services in Australia) prior to this study and supported by prior local retrospective audits at the Canberra Hospital and Bankstown-Lidcombe Hospital HITH services
All HITH patients are admitted to the respective HITH Unit under the care of an admitting medical specialist and are seen at least once daily by a HITH nurse who checks on the PIVC site daily and changes over the antibiotic infusion daily. The nurse also measures the patients vital signs are how they are responding to the antibiotic therapy at this visit - which most often occurs in the patients home but may also occur at the HITH Unit clinical base. This daily check of the PIVC is routine nursing care and is recorded in the patient medical record to note that the PIVC site is patent and noninflamed (including the recording of a VIP (Visual Infusion Phlebitis) score each day. Whilst this is already standard practice, there is also a specific data collection form that has been developed for the study to reinforce the data that is being requested for the purpose of this study.
It is standard practice at all sites (as per general hospital PIVC management policy) to change the PIVC every 72 hours (if it is still required). The PIVC will also be replaced earlier than 72 hours if there are any signs of inflammation, bleeding, infiltration, occlusion etc as per the data collection form and as standard practice. At The Canberra Hospital it is authorised that PIVCs inserted by the IVAT (IV Access Team) nurses under ultrasound guidance using sterile technique may be left in situ until the removal of the PIVC is clinically indicated rather than every 72 hours - this may be because IV antibiotic therapy is no longer indicated or because there are PIVC site issues as above.
The PIVC and antibiotic infusion is largely managed by the HITH nurses as above but patients (and/or carer) are educated about issues to look out for in terms of the cannula (eg signs of inflammation such as pain and redness) and the infusion (eg infusion bottle not emptying as anticipated over the 24 hour period) and to phone the HITH nursing team if these issues occur between daily nursing visits
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Intervention code [1]
330481
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Not applicable
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Comparator / control treatment
There will be no specific control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340622
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PIVC dislodgement rate
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Assessment method [1]
340622
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Recording on patient data collection form if PIVC dislodgement occurs - this is a separate outcome of many potential outcomes
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Timepoint [1]
340622
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For the duration of continuous intravenous (IV) antibiotic infusion therapy being administered by HITH - this will be determined daily by whether there is an ongoing clinical need for IV antibiotics or not within a 2 week period, If it is thought that a patient is likely to require IV antibiotic therapy for more than 2 weeks then an alternate means of IV access (such as a PICC - Peripherally Inserted Central Catheter) would be used rather than a PIVC and the patient would therefore not meet study inclusion criteria once a PICC rather than a PIVC is being utilised for the purpose of an IV antibiotic infusion
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Primary outcome [2]
340623
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PIVC surrounding tissue infiltration requiring PIVC replacement
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Assessment method [2]
340623
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Daily recording on patient data collection form of any PIVC related issues - including any tissue infiltration
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Timepoint [2]
340623
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Primary outcome [3]
340624
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PIVC occlusion requiring PIVC replacement rate
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Assessment method [3]
340624
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Daily recording on patient data collection form of any PIVC related issues - including PIVC occlusion
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Timepoint [3]
340624
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [1]
444628
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PIVC Inflammation requiring PIVC replacement (primary outcome)
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Assessment method [1]
444628
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Daily recording on patient data collection form of any PIVC related issues - including daily Visual Infusion Phlebitis (VIP) score,
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Timepoint [1]
444628
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [2]
444629
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PIVC related venous thrombosis
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Assessment method [2]
444629
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Daily recording on patient data collection form of any PIVC related issues - including incidence of venous thrombosis as a cause of occlusion/inflammation
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Timepoint [2]
444629
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [3]
444630
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PIVC related infection - local
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Assessment method [3]
444630
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Daily recording on patient data collection form of any PIVC related issues - including evidence of cannula site infection as a cause of inflammation
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Timepoint [3]
444630
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [4]
444631
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PIVC related bacteraemia
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Assessment method [4]
444631
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Recording of any PIVC related issues - including incidence of any systemic infection that occurs that may be due to PIVC related bacteraemia
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Timepoint [4]
444631
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [5]
444632
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Antibiotic Infusor Device residual volume at time of daily nursing visit for changeover of device
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Assessment method [5]
444632
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Daily recording on patient data collection form of what the elastomeric infusion device residual volume is at daily nurse visit (with pictorial prompt indicating empty, 3/4 empty, 1/2 empty, 1/4 empty or full)
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Timepoint [5]
444632
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [6]
444633
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Patient Satisfaction
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Assessment method [6]
444633
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Patient satisfaction survey that was developed specifically for this study
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Timepoint [6]
444633
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Administered at point of discharge from HITH for purpose of continuous IV antibiotic infusion
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Secondary outcome [7]
444634
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Assessment as to whether patient comorbidities contribute to incidence of complications
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Assessment method [7]
444634
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Charlson Comorbidity Index
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Timepoint [7]
444634
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Co-morbidities will be recorded at time of patient recruitment and consent and converted into a Charlson Comorbidity Index score
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Secondary outcome [8]
445009
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Incidence of PIVC damage necessitating PIVC removal and replacement (primary outcome)
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Assessment method [8]
445009
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Recording of any PIVC related issues - including PIVC damage This will be recorded on the patient data collection form as well as in the patient medical record
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Timepoint [8]
445009
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [9]
445010
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Incidence of PIVC removal by patient (primary outcome)
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Assessment method [9]
445010
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Recording of any PIVC related issues - including PIVC removal by patient This will be recorded on the patient data collection form as well as in the patient medical record
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Timepoint [9]
445010
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Secondary outcome [10]
445011
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Incidence of PIVC removal at request of patient/family (primary outcome)
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Assessment method [10]
445011
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Recording of any PIVC related issues - including patient/family request to remove PIVC This will be recorded on the patient data collection form as well as in the patient medical record
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Timepoint [10]
445011
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For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
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Eligibility
Key inclusion criteria
Patients transferred/directly admitted to HITH for the purpose of administration of a continuous intravenous antibiotic infusion, using an elastomeric infusion device, via a peripheral intravenous cannula.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who receive intravenous antibiotics via a central venous access device or receiving short duration infusion (< 12 hours) or intermittent bolus IV antibiotics – this may include patients with significant cognitive impairment who are assessed as being unlikely to manage being continuously attached to an infusion line/device but who may cope with a peripheral cannula remaining in situ so long as it is covered up when not in use
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Study design
Purpose
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Initial descriptive analysis of data, especially the determination of PIVC complication frequencies and rates to demonstrate the incidence of any unwanted effects – especially reporting on overall cannula failure rate for any reason, tissue infiltration, occlusion and dislodgment rates to match what is reported in the literature with the potential for an increased risk when these occurrences happen for patients at home with no immediate nursing support. Also rates of PIVC associated blood stream infection, local infection, phlebitis, pain and patient compliance and infusor issues; tabulation of patient responses to questionnaire items and thematic analysis of patient comments provided.
Univariate and multivariate statistical analyses of data - there is intention to involve biostatisticians in the results analysis
The intention is to closely match data collection and analysis such that the results can be more readily compared with 2 recently published systematic review and meta-analyses (Marsh, N., Larsen, E. N., et al (2024). Peripheral intravenous catheter infection and failure: A systematic review and meta-analysis. International Journal of Nursing Studies, 151, https://doi.org/https://doi.org/10.1016/j.ijnurstu.2023.104673 and
Marsh N, Webster J, et al (2020). Peripheral intravenous catheter non-infectious complications in adults: A systematic review and meta-analysis. J. Adv. Nurs.. 2020;76:3346–3362. wileyonlinelibrary.com/journal/jan, DOI: 10.1111/jan.14565).
Means and confidence intervals will be reported to allow comparison of our data with that in the literature to hopefully then demonstrate trends to non-inferiority or superiority in our processes by showing a narrow confidence interval, with this likelihood being more demonstrable with a larger sample size – with intention to recruit at least 300 patients as determined by ANU (Australian National University) statisticians that were engaged to assist in calculating an appropriate sample size
We have added an extra site (Rockhampton Hospital) to when this initial sample size analysis was performed for Canberra Hospital, Bankstown Lidcombe Hospital and Townsville University Hospital, such that we anticipate reaching this 300 patient goal at an earlier time now and may choose to go above this 300 patient minimum if resources permit
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
4/03/2025
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Date of last participant enrolment
Anticipated
29/06/2025
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Actual
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Date of last data collection
Anticipated
13/07/2025
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Actual
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Sample size
Target
300
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Accrual to date
30
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
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Recruitment hospital [1]
27605
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The Canberra Hospital - Garran
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Recruitment hospital [2]
27606
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [3]
27607
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Rockhampton Base Hospital - Rockhampton
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Recruitment hospital [4]
27608
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Townsville University Hospital - Douglas
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Recruitment postcode(s) [1]
43778
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2605 - Garran
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Recruitment postcode(s) [2]
43779
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2200 - Bankstown
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Recruitment postcode(s) [3]
43780
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4700 - Rockhampton
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Recruitment postcode(s) [4]
43781
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4814 - Douglas
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Funding & Sponsors
Funding source category [1]
318361
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Government body
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Name [1]
318361
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Canberra Health Services (The Canberra Hospital)
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Address [1]
318361
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Country [1]
318361
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Australia
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Funding source category [2]
318404
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University
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Name [2]
318404
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Australian National University
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Address [2]
318404
0
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Country [2]
318404
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Australia
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Funding source category [3]
318405
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Government body
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Name [3]
318405
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NSW Health
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Address [3]
318405
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Country [3]
318405
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Australia
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Funding source category [4]
318406
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Government body
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Name [4]
318406
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Queensland Health
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Address [4]
318406
0
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Country [4]
318406
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Australia
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Primary sponsor type
Government body
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Name
Canberra Health Services
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Address
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Country
Australia
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Secondary sponsor category [1]
320764
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University
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Name [1]
320764
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Australian National University (ANU)
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Address [1]
320764
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Country [1]
320764
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Australia
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Secondary sponsor category [2]
320796
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Hospital
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Name [2]
320796
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Bankstown Lidcombe Hospital
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Address [2]
320796
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Country [2]
320796
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Australia
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Secondary sponsor category [3]
320797
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Government body
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Name [3]
320797
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Central Queensland Hospital and Health Service
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Address [3]
320797
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Country [3]
320797
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316994
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ACT Health Human Research Ethics Committee
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Ethics committee address [1]
316994
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https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
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Ethics committee country [1]
316994
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Australia
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Date submitted for ethics approval [1]
316994
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30/09/2024
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Approval date [1]
316994
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13/11/2024
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Ethics approval number [1]
316994
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ACT reference 2024.LRE.00240 Regis reference 2024/ETH02165
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Summary
Brief summary
This will be a multicentre (4 Australian HITH services) prospective cohort study where the patient population will be Hospital in the Home (HITH) patients prescribed short term (<2 weeks) continuous antibiotics as an infusion via a Peripheral Intravenous Cannula (PIVC). Patient demographics and comorbidities will be recorded along with prospective data collection on initial PIVC insertion reason and process details, with PIVC and patient outcomes recorded until the time of PIVC removal. A written, short patient survey will also be conducted to establish patient perception and satisfaction of this type of treatment. This means of continuous intravenous antibiotic infusion via a PIVC will be compared to anticipated PIVC complication rates generally (PIVC inserted for any reason) as reported in the literature and to anticipated Peripherally Inserted Central Catheter (PICC) complication rates.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
139686
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Dr Karyn Cuthbert
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Address
139686
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The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
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Country
139686
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Australia
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Phone
139686
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+61 04 04392522
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Fax
139686
0
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Email
139686
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[email protected]
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Contact person for public queries
Name
139687
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Karyn Cuthbert
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Address
139687
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The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
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Country
139687
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Australia
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Phone
139687
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+61 2 51240000
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Fax
139687
0
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Email
139687
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[email protected]
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Contact person for scientific queries
Name
139688
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Karyn Cuthbert
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Address
139688
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The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
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Country
139688
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Australia
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Phone
139688
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+61 2 51240000
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Fax
139688
0
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Email
139688
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Data will be de-identified for the purposes of data assessment and reporting
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24549
Ethical approval
8.10 - 2024.LRE.00240 - Cuthbert - Reissued.pdf
24552
Study protocol
ACT Low Risk Protocol HITH Antibiotic Infusion - V4 - 28.11.24 No tracking.doc
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF