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Trial registered on ANZCTR
Registration number
ACTRN12607000537459
Ethics application status
Approved
Date submitted
18/10/2007
Date registered
19/10/2007
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Date results provided
29/06/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised, controlled trial of exit site application of MedihoneyTM Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients, The HONEYPOT Study
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Scientific title
A randomised, controlled trial of exit site application of MedihoneyTM Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients
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Secondary ID [1]
478
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Australasian Kidney Trials Network trial number 06.02
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Universal Trial Number (UTN)
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Trial acronym
HONEYPOT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peritoneal dialysis
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Chronic renal failure
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Condition category
Condition code
Renal and Urogenital
2536
2536
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0
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Kidney disease
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Alternative and Complementary Medicine
2537
2537
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Daily exit site application of gamma-irradiated, commercially available, pooled antibacterial honeys including Leptospermum sp honey (Medihoney™ Antibacterial Wound Gel, Medihoney Pty Ltd, Australia; approximately 10 mg) following exit site cleaning and drying as per standard local practice for the duration of the study. Trial participants will be treated and followed up for 12 months from the entry of the last patient in the study. Recruitment is expected to take 2 years and median trial treatment and follow up is expected to be 18 months.
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Intervention code [1]
2168
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Prevention
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Comparator / control treatment
All control group patients will undertake daily exit site cleaning as per standard local practice for the duration of the study. Identified nasal carriers of Staphylococcus aureus will undergo intra-nasal application of 2% mupirocin ointment (GlaxoSmithKline, Australia) bd for 5 consecutive days each month for the duration of the trial (in accordance with the Caring for Australians with Renal Impairment (CARI) Guideline recommendations). Members of the control group who do not have nasal staphylococcal colonization will not receive mupirocin.
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Control group
Active
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Outcomes
Primary outcome [1]
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Time to first episode of exit site infection, tunnel infection or peritonitis (whichever comes first)
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Assessment method [1]
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Timepoint [1]
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Time from study entry
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Secondary outcome [1]
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Costs
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Assessment method [1]
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Timepoint [1]
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Assessed throughout the study period
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Secondary outcome [2]
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Time to first episode of peritonitis
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Assessment method [2]
5767
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Timepoint [2]
5767
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Time from study entry
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Secondary outcome [3]
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Time to first tunnel infection
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Assessment method [3]
5768
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Timepoint [3]
5768
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Time from study entry
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Secondary outcome [4]
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Time to first exit site infection
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Assessment method [4]
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Timepoint [4]
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Time from study entry
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Secondary outcome [5]
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Time to infection-associated catheter removal
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Assessment method [5]
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Timepoint [5]
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Time from study entry
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Secondary outcome [6]
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Catheter-associated infection rates
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Assessment method [6]
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Timepoint [6]
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Assessed throughout the study period
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Secondary outcome [7]
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Occurrence of mupirocin-resistant microbial isolates
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Assessment method [7]
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Timepoint [7]
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Assessed throughout the study period
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Secondary outcome [8]
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Incidence of adverse reactions
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Assessment method [8]
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Timepoint [8]
5773
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Assessed throughout the study period
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Eligibility
Key inclusion criteria
Receiving peritoneal dialysis.
Able to give informed consent.
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Minimum age
No limit
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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 with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study. Recent (within 1 month) exit site infection, peritonitis, or tunnel infection. Known hypersensitivity to, or intolerance of, honey or mupirocin. On long term antibiotics. Nasal carriage of mupirocin resistant Staphylococcus aureus.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from hospital renal units providing peritoneal dialysis services in Australia and New Zealand. Patients should meet the inclusion and exclusion criteria. Eligible patients will be provided with an information and consent form. Once written consent has been obtained, study staff will randomise the patient using a web based system. Patients will be informed of the randomisation result.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted utilising a web-based database to allocate the patient to a trial arm using dynamically allocated methods. Stratification will occur for study site, incident versus prevalent patient status and nasal carriage of Staph aureus. Patients will be randomised to one of two treatment groups in equal proportion.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2008
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Actual
17/09/2008
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Date of last participant enrolment
Anticipated
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Actual
17/06/2011
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Date of last data collection
Anticipated
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Actual
29/01/2013
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Sample size
Target
370
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Accrual to date
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Final
371
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
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Recruitment postcode(s) [1]
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7250
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Recruitment postcode(s) [2]
294
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5011
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Recruitment postcode(s) [3]
295
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5041
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Recruitment postcode(s) [4]
296
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5000
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Recruitment postcode(s) [5]
297
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6160
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Recruitment postcode(s) [6]
298
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6001
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Recruitment postcode(s) [7]
299
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2050
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Recruitment postcode(s) [8]
300
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4029
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Recruitment postcode(s) [9]
468
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4102
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Recruitment postcode(s) [10]
469
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4560
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Recruitment postcode(s) [11]
470
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4350
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Recruitment postcode(s) [12]
471
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4814
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Recruitment postcode(s) [13]
472
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4120
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Recruitment postcode(s) [14]
473
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2170
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Recruitment postcode(s) [15]
474
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2139
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Recruitment postcode(s) [16]
475
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2145
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Recruitment postcode(s) [17]
476
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2800
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Recruitment postcode(s) [18]
477
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2148
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Recruitment postcode(s) [19]
478
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3168
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Recruitment postcode(s) [20]
479
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3550
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Recruitment postcode(s) [21]
480
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3220
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Recruitment postcode(s) [22]
481
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3021
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Recruitment postcode(s) [23]
482
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3065
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Recruitment outside Australia
Country [1]
618
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New Zealand
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State/province [1]
618
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North & South Islands
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Queensland Health - Smart Health Grant
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Address [1]
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147-163 Charlotte Street, Brisbane Queensland 4000
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Baxter Renal Discoveries Extramural Grant
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Address [2]
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One Baxter Parkway, Deerfield, IL 60015-4625
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Country [2]
269850
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United States of America
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Primary sponsor type
University
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Name
Australasian Kidney Trials Network
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Address
University of Queensland at Ground Floor, Building 33, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Brisbane 4102
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
2463
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Country [1]
2463
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Medical Research Ethics Committee
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Ethics committee address [1]
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University of Queensland, St Lucia, Brisbane 4072
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/05/2007
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Approval date [1]
4640
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04/07/2007
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Ethics approval number [1]
4640
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2007000591
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Summary
Brief summary
The largest problem faced by peritoneal dialysis patients is infection of their dialysis catheter, which can occur at the point of entry of the catheter into the belly (exit site infection), along the catheter tunnel (tunnel infection) or inside the belly (peritonitis). Such infections are the commonest cause of death or failure of treatment in peritoneal dialysis patients at Princess Alexandra Hospital. Recent studies have suggested that honey may be a promising agent for preventing catheter-associated infections. Honey has natural antibacterial and antifungal actions and has been shown to be very effective in preventing infection when applied to a variety of wounds, including burns, ulcers and surgical wounds. A previous controlled trial by our group in haemodialysis patients showed that honey was as effective as, and less likely to select resistant germs than, standard antibiotic ointment (mupirocin). The purpose of the present proposed study is to determine if exit site application of standardised antibacterial honey (Medihoney Wound Gel) is more effective at preventing infection of peritoneal dialysis catheters than the standard antibiotic ointment, mupirocin, which is currently recommended by national guidelines.
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Trial website
www.aktn.org.au
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Trial related presentations / publications
Johnson DW, Clark C, Isbel NM, Hawley CM, Beller E, Cass A, de Zoysa J,McTaggart S, Playford G, Rosser B, Thompson C, Snelling P; the HONEYPOT Study Group. THE HONEYPOT STUDY PROTOCOL: A RANDOMIZED CONTROLLED TRIAL OF EXIT-SITE APPLICATION OF MEDIHONEY ANTIBACTERIAL WOUND GEL FOR THE PREVENTION OF CATHETER-ASSOCIATED INFECTIONS IN PERITONEAL DIALYSIS PATIENTS. Perit Dial Int. 2009 May; 29(3):303-309.2007 Impact factor: 1.995 Badve, Sunil; Smith, Alicia; Hawley, Carmel; Johnson, David W. Letter: ADHERENCE TO GUIDELINE RECOMMENDATIONS FOR INFECTION PROPHYLAXIS IN PERITONEAL DIALYSIS PATIENTS. NDT Plus. 2009 December; 2(6): 508. Pascoe EM, Lo, S, Scaria, A, Badve SV, Beller EM, Cass A, Hawley CM, Johnson DW. The HONEYPOT RANDOMIZED CONTROLLED TRIAL STATISTICAL ANALYSIS PLAN. Perit Dial Inter. July-August 2013 33(4): 426-435 David W Johnson, Sunil V Badve, Elaine M Pascoe, Elaine Beller, Alan Cass, Carolyn Clark, Janak de Zoysa, Nicole M Isbel, Steven McTaggart, Alicia T Morrish, E Geoff rey Playford, Anish Scaria, Paul Snelling, Liza A Vergara, Carmel M Hawley, for the HONEYPOT Study Collaborative Group. Antibacterial honey for the prevention of peritoneal dialysis- related infections (HONEYPOT): a randomised trial. The Lancet Infectious Diseases 2014; 14(1): 23-30 Lei Zhang, Sunil V. Badve, Elaine M. Pascoe, Elaine Beller, Alan Cass, Carolyn Clark, Janak de Zoysa, Nicole M Isbel, Steven McTaggart, Alicia T. Morrish, Geoffrey Playford, Anish Scaria, Paul Snelling, Liza A. Vergara, Carmel M. Hawley, and David W. Johnson for the HONEYPOT Study Collaborative Group. The effect of exit site antibacterial honey versus nasal mupirocin prophylaxis on the microbiology and outcomes of peritoneal dialysis-associated peritonitis and exit site infections: a sub-study of the HONEYPOT trial. Accepted by PDI (PDI-2014-00206.R1), waiting for reference
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Public notes
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Contacts
Principal investigator
Name
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Prof David Johnson
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Address
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Australasian Kidney Trials Network (UQ) Ground Floor, Bldg 33 Princess Alexandra Hospital 199 Ipswich Road, WOOLLOONGABBA QLD 4102
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Country
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Australia
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Phone
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+61 7 3176 5463
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Alicia Morrish
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Address
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Australasian Kidney Trials Network (UQ)
Ground Floor, Bldg 33
Princess Alexandra Hospital
199 Ipswich Road,
WOOLLOONGABBA QLD 4102
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Country
11255
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Australia
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Phone
11255
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+61 7 3443 5463
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Fax
11255
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07 3176 5663
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Email
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[email protected]
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Contact person for scientific queries
Name
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David Johnson
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Address
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Department of Nephrology, ARTS Building, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Brisbane 4102
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Country
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Australia
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Phone
2183
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61 7 3240 5080
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Fax
2183
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61 7 3240 5480
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Email
2183
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
12353
Statistical analysis plan
https://aktn.org.au
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The effect of exit-site antibacterial honey versus nasal mupirocin prophylaxis on the microbiology and outcomes of peritoneal dialysis-associated peritonitis and exit-site infections: A sub-study of the Honeypot trial.
2015
https://dx.doi.org/10.3747/pdi.2014.00206
N.B. These documents automatically identified may not have been verified by the study sponsor.
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