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Trial registered on ANZCTR


Registration number
ACTRN12618000452291
Ethics application status
Approved
Date submitted
28/02/2018
Date registered
28/03/2018
Date last updated
28/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Utilisation of ambulatory pumps in the inpatient setting to administer long term antibiotic therapy: A patient risk reduction and rehabilitation Strategy (The MOBILISE Study)
Scientific title
Utilisation of ambulatory pumps in the inpatient setting to administer long term antibiotic therapy: A patient risk reduction and rehabilitation Strategy (The MOBILISE Study)
Secondary ID [1] 294107 0
None
Universal Trial Number (UTN)
Trial acronym
MOBILISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility 306700 0
Condition category
Condition code
Public Health 306036 306036 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ambulatory pump for a continuous infusion of antibiotics, called Ambit pump, will be used to administer the prescribed antibiotic. The Ambit pump is a small device, about the size and weight of a TV remote, that will be carried in a provided bum bag. The duration and type of antibiotic treatment will be dependent on the participant's ailment and that chosen by the treating medical team. For the purposes of this study the potential treatment minimum period will be 24 hours and the maximum period of treatment will be 7 days.
Intervention code [1] 300387 0
Treatment: Devices
Comparator / control treatment
The standard administration system via the use of a pump/pole and intermittent antibiotic administration. This is the standard system where the patient is connected to an intravenous infusion, which provides the prescribed antibiotic at the required intervals depending on type of antibiotic. The duration and type of antibiotic treatment will be dependent on the participant's ailment and that chosen by the treating medical team.
Control group
Active

Outcomes
Primary outcome [1] 304864 0
The total time spent performing light or moderate activity over a 24 hour period as measured by GENEActiv device strapped to the patient's ankle.
Timepoint [1] 304864 0
Activity will be measured by day (24hrs) units up to 7 days, as measured by the GENEActiv device strapped to the patient's ankle. The outcome will be Assessed at day 7 of study participation or at the time of participant discharged from the hospital if the participant is discharged prior to 7 days. The measure will be the median total time spent performing light/moderate activity over a 24hr period .
Secondary outcome [1] 343407 0
Infectious diseases condition outcome at 3 months post inclusion in the study assessed by review of medical record specifically reviewing the clinical records of the Infectious Diseases team.
Timepoint [1] 343407 0
3 months post day 1 of inclusion into the study.
Secondary outcome [2] 343409 0
Composite outcome regarding nursing time spent performing PICC/pump care, preparing and administering antibiotics assessed by study-specific questionnaire.
Timepoint [2] 343409 0
Assessed at day 7 of study participation or at the time of participant discharged from the hospital if the participant is discharged prior to 7 days.
Secondary outcome [3] 343412 0
Nursing satisfaction score as assessed by the study-specific questionnaire.
Timepoint [3] 343412 0
Assessed at day 7 of study participation or at the time of participant discharged from the hospital if the participant is discharged prior to 7 days.
Secondary outcome [4] 343414 0
Patient satisfaction score as assessed by a study-specific questionnaire.
Timepoint [4] 343414 0
Assessed at day 7 of study participation or at the time of participant discharged from the hospital if the participant is discharged prior to 7 days.

Eligibility
Key inclusion criteria
1. Age greater than 18 years;
2. Have a PICC line in-situ with a line dedicated to only be used for antibiotic administration;
3. Require an antibiotic that is considered stable for administration by either a 12 or 24 hour infusion (i.e. benzylpenicillin, flucloxacillin, cephazolin, ceftazidime, cefepime, ceftolazone-tazobactam, lincomycin, piperacillin-tazobactam and vancomycin);
4. The antibiotic selection is definitive based on the patient’s condition or microbiological results and not empirical,
5. One lumen of the PICC line is dedicated to antibiotic administration only
6. The patient is able to mobilize at baseline i.e. not wheel chair bound or bed bound or attached to monitors/medical equipment/receiving dressings that do not allow patient movement around the hospital and are at least 48 hours post their last surgical procedure. The patient is expected to mobilise independently at discharge from hospital;
7. Do not reside at a nursing home;
8. The patient has the ability to provide informed consent to enter the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient will be removed from the study if less than 24 hours of antibiotics are received while enrolled in the study;
2. The patient is unwilling to wear the GENEactiv device on their ankle with the ankle strap;
3. The patient is unable or unwilling to look after the pump and antibiotic bag adequately;
4. The patient is unable to wear the accelerometer on their ankle for reasons such as wounds, heart failure, dressings and amputation
5. The patient is unwilling to complete the exit patient survey regarding their satisfaction with the pump and antibiotic administration.
6. Planned surgery in the week post expected enrolment onto the trial.
7. The patient is expected to be discharged from the acute hospital setting within the first 24 hours post enrolment to the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The MOBILISE study is a single-centre, prospective, randomised controlled trial with 1:1 allocation of patients to receive either an ambulatory pump with a continuous infusion of antibiotics or a standard pump/pole and intermittent antibiotic administration. Due to the visibility of the devices utilised the study will be an open-label study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be utilised to summarize patient characteristics and response to surveys. The patient’s median activity time, median time of nursing antibiotic/pump care time, frequency of pump complications, frequency of patient outcome at 3 months and total length of inpatient stay between the two groups will be compared using the chi squared test or Fishers exact test. Patient and nurse satisfaction with care will be assessed using the Wilcoxon signed rank test of survey data. Subgroup analysis of patient activity based on site of infectious disease and type of infectious disease will also occur. A cost analysis of the differing methods of administration of antibiotics will also be performed based on current hospital cost data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10072 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 21598 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 298743 0
Charities/Societies/Foundations
Name [1] 298743 0
Royal Brisbane and Women's Hospital Foundation
Address [1] 298743 0
Block 20 Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4006
Country [1] 298743 0
Australia
Primary sponsor type
University
Name
University of Queensland Centre for Clinical Research
Address
UQ Centre for Clinical Research (UQCCR)
Building 71/918 Royal Brisbane Hospital, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 297921 0
None
Name [1] 297921 0
Address [1] 297921 0
Country [1] 297921 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299682 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 299682 0
Royal Brisbane and WOmens Hospital
Level7 Block 7
Butterfield Street, Herston QLD 4029
Ethics committee country [1] 299682 0
Australia
Date submitted for ethics approval [1] 299682 0
23/11/2017
Approval date [1] 299682 0
19/02/2018
Ethics approval number [1] 299682 0
HREC/17/QRBW/679

Summary
Brief summary
The MOBILISE study is a randomised control trial comparing antibiotic administration via a small pump with a continuous antibiotic infusion to the traditional method of a hospital pump and pole with multiple daily dosing of antibiotics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81278 0
Dr Kate McCarthy
Address 81278 0
Paterson Group, UQ Centre for Clinical Research (UQCCR)
Level 8, Building 71/918 Royal Brisbane Hospital, Herston QLD 4029
Country 81278 0
Australia
Phone 81278 0
+61 7 3346 6072
Fax 81278 0
Email 81278 0
kate.mccarthy4@health.qld.gov.au
Contact person for public queries
Name 81279 0
Dr Kate McCarthy
Address 81279 0
Paterson Group, UQ Centre for Clinical Research (UQCCR)
Level 8, Building 71/918 Royal Brisbane Hospital, Herston QLD 4029
Country 81279 0
Australia
Phone 81279 0
+61 7 3346 6072
Fax 81279 0
Email 81279 0
kate.mccarthy4@health.qld.gov.au
Contact person for scientific queries
Name 81280 0
Dr Kate McCarthy
Address 81280 0
Paterson Group, UQ Centre for Clinical Research (UQCCR)
Level 8, Building 71/918 Royal Brisbane Hospital, Herston QLD 4029
Country 81280 0
Australia
Phone 81280 0
+61 7 3346 6072
Fax 81280 0
Email 81280 0
kate.mccarthy4@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results