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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
Scientific title
Continuous intravenous antibiotic infusion administered via a peripheral intravenous cannula in the Hospital in the Home (HITH) setting
Secondary ID [1] 313894 0
None
Universal Trial Number (UTN)
U1111-1318-7901
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infections requiring intravenous antibiotic treatment 336576 0
Condition category
Condition code
Infection 333086 333086 0 0
Studies of infection and infectious agents
Public Health 333087 333087 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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

Intervention code [1] 330481 0
Not applicable
Comparator / control treatment
There will be no specific control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340622 0
PIVC dislodgement rate
Timepoint [1] 340622 0
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
Primary outcome [2] 340623 0
PIVC surrounding tissue infiltration requiring PIVC replacement
Timepoint [2] 340623 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Primary outcome [3] 340624 0
PIVC occlusion requiring PIVC replacement rate
Timepoint [3] 340624 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [1] 444628 0
PIVC Inflammation requiring PIVC replacement (primary outcome)
Timepoint [1] 444628 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [2] 444629 0
PIVC related venous thrombosis
Timepoint [2] 444629 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [3] 444630 0
PIVC related infection - local
Timepoint [3] 444630 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [4] 444631 0
PIVC related bacteraemia
Timepoint [4] 444631 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [5] 444632 0
Antibiotic Infusor Device residual volume at time of daily nursing visit for changeover of device
Timepoint [5] 444632 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [6] 444633 0
Patient Satisfaction
Timepoint [6] 444633 0
Administered at point of discharge from HITH for purpose of continuous IV antibiotic infusion
Secondary outcome [7] 444634 0
Assessment as to whether patient comorbidities contribute to incidence of complications
Timepoint [7] 444634 0
Co-morbidities will be recorded at time of patient recruitment and consent and converted into a Charlson Comorbidity Index score
Secondary outcome [8] 445009 0
Incidence of PIVC damage necessitating PIVC removal and replacement (primary outcome)
Timepoint [8] 445009 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [9] 445010 0
Incidence of PIVC removal by patient (primary outcome)
Timepoint [9] 445010 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks
Secondary outcome [10] 445011 0
Incidence of PIVC removal at request of patient/family (primary outcome)
Timepoint [10] 445011 0
For the duration of intravenous (IV) antibiotic infusion therapy being administered by HITH via PIVC which could be for up to 2 weeks

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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/03/2025
Date of last participant enrolment
Anticipated
29/06/2025
Actual
Date of last data collection
Anticipated
13/07/2025
Actual
Sample size
Target
300
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 27605 0
The Canberra Hospital - Garran
Recruitment hospital [2] 27606 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 27607 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [4] 27608 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 43778 0
2605 - Garran
Recruitment postcode(s) [2] 43779 0
2200 - Bankstown
Recruitment postcode(s) [3] 43780 0
4700 - Rockhampton
Recruitment postcode(s) [4] 43781 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 318361 0
Government body
Name [1] 318361 0
Canberra Health Services (The Canberra Hospital)
Country [1] 318361 0
Australia
Funding source category [2] 318404 0
University
Name [2] 318404 0
Australian National University
Country [2] 318404 0
Australia
Funding source category [3] 318405 0
Government body
Name [3] 318405 0
NSW Health
Country [3] 318405 0
Australia
Funding source category [4] 318406 0
Government body
Name [4] 318406 0
Queensland Health
Country [4] 318406 0
Australia
Primary sponsor type
Government body
Name
Canberra Health Services
Address
Country
Australia
Secondary sponsor category [1] 320764 0
University
Name [1] 320764 0
Australian National University (ANU)
Address [1] 320764 0
Country [1] 320764 0
Australia
Secondary sponsor category [2] 320796 0
Hospital
Name [2] 320796 0
Bankstown Lidcombe Hospital
Address [2] 320796 0
Country [2] 320796 0
Australia
Secondary sponsor category [3] 320797 0
Government body
Name [3] 320797 0
Central Queensland Hospital and Health Service
Address [3] 320797 0
Country [3] 320797 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316994 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316994 0
Ethics committee country [1] 316994 0
Australia
Date submitted for ethics approval [1] 316994 0
30/09/2024
Approval date [1] 316994 0
13/11/2024
Ethics approval number [1] 316994 0
ACT reference 2024.LRE.00240 Regis reference 2024/ETH02165

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

Contacts
Principal investigator
Name 139686 0
Dr Karyn Cuthbert
Address 139686 0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Country 139686 0
Australia
Phone 139686 0
+61 04 04392522
Fax 139686 0
Email 139686 0
[email protected]
Contact person for public queries
Name 139687 0
Karyn Cuthbert
Address 139687 0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Country 139687 0
Australia
Phone 139687 0
+61 2 51240000
Fax 139687 0
Email 139687 0
[email protected]
Contact person for scientific queries
Name 139688 0
Karyn Cuthbert
Address 139688 0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Country 139688 0
Australia
Phone 139688 0
+61 2 51240000
Fax 139688 0
Email 139688 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24549Ethical approval    8.10 - 2024.LRE.00240 - Cuthbert - Reissued.pdf
24552Study 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.