Trial Review

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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 information initially 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
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
Secondary ID [1] 478 0
Australasian Kidney Trials Network trial number 06.02
Universal Trial Number (UTN)
Trial acronym
HONEYPOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal dialysis 2439 0
Chronic renal failure 2451 0
Condition category
Condition code
Renal and Urogenital 2536 2536 0 0
Kidney disease
Alternative and Complementary Medicine 2537 2537 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 2168 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 3459 0
Time to first episode of exit site infection, tunnel infection or peritonitis (whichever comes first)
Timepoint [1] 3459 0
Time from study entry
Secondary outcome [1] 5718 0
Costs
Timepoint [1] 5718 0
Assessed throughout the study period
Secondary outcome [2] 5767 0
Time to first episode of peritonitis
Timepoint [2] 5767 0
Time from study entry
Secondary outcome [3] 5768 0
Time to first tunnel infection
Timepoint [3] 5768 0
Time from study entry
Secondary outcome [4] 5769 0
Time to first exit site infection
Timepoint [4] 5769 0
Time from study entry
Secondary outcome [5] 5770 0
Time to infection-associated catheter removal
Timepoint [5] 5770 0
Time from study entry
Secondary outcome [6] 5771 0
Catheter-associated infection rates
Timepoint [6] 5771 0
Assessed throughout the study period
Secondary outcome [7] 5772 0
Occurrence of mupirocin-resistant microbial isolates
Timepoint [7] 5772 0
Assessed throughout the study period
Secondary outcome [8] 5773 0
Incidence of adverse reactions
Timepoint [8] 5773 0
Assessed throughout the study period

Eligibility
Key inclusion criteria
Receiving peritoneal dialysis.
Able to give informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
17/09/2008
Date of last participant enrolment
Anticipated
Actual
17/06/2011
Date of last data collection
Anticipated
Actual
29/01/2013
Sample size
Target
370
Accrual to date
Final
371
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 293 0
7250
Recruitment postcode(s) [2] 294 0
5011
Recruitment postcode(s) [3] 295 0
5041
Recruitment postcode(s) [4] 296 0
5000
Recruitment postcode(s) [5] 297 0
6160
Recruitment postcode(s) [6] 298 0
6001
Recruitment postcode(s) [7] 299 0
2050
Recruitment postcode(s) [8] 300 0
4029
Recruitment postcode(s) [9] 468 0
4102
Recruitment postcode(s) [10] 469 0
4560
Recruitment postcode(s) [11] 470 0
4350
Recruitment postcode(s) [12] 471 0
4814
Recruitment postcode(s) [13] 472 0
4120
Recruitment postcode(s) [14] 473 0
2170
Recruitment postcode(s) [15] 474 0
2139
Recruitment postcode(s) [16] 475 0
2145
Recruitment postcode(s) [17] 476 0
2800
Recruitment postcode(s) [18] 477 0
2148
Recruitment postcode(s) [19] 478 0
3168
Recruitment postcode(s) [20] 479 0
3550
Recruitment postcode(s) [21] 480 0
3220
Recruitment postcode(s) [22] 481 0
3021
Recruitment postcode(s) [23] 482 0
3065
Recruitment outside Australia
Country [1] 618 0
New Zealand
State/province [1] 618 0
North & South Islands

Funding & Sponsors
Funding source category [1] 2727 0
Government body
Name [1] 2727 0
Queensland Health - Smart Health Grant
Country [1] 2727 0
Australia
Funding source category [2] 269850 0
Commercial sector/Industry
Name [2] 269850 0
Baxter Renal Discoveries Extramural Grant
Country [2] 269850 0
United States of America
Primary sponsor type
University
Name
Australasian Kidney Trials Network
Address
University of Queensland at Ground Floor, Building 33, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Brisbane 4102
Country
Australia
Secondary sponsor category [1] 2463 0
None
Name [1] 2463 0
Address [1] 2463 0
Country [1] 2463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4640 0
Medical Research Ethics Committee
Ethics committee address [1] 4640 0
University of Queensland, St Lucia, Brisbane 4072
Ethics committee country [1] 4640 0
Australia
Date submitted for ethics approval [1] 4640 0
01/05/2007
Approval date [1] 4640 0
04/07/2007
Ethics approval number [1] 4640 0
2007000591

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.
Trial website
www.aktn.org.au
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
Public notes

Contacts
Principal investigator
Name 28098 0
Prof David Johnson
Address 28098 0
Australasian Kidney Trials Network (UQ) Ground Floor, Bldg 33 Princess Alexandra Hospital 199 Ipswich Road, WOOLLOONGABBA QLD 4102
Country 28098 0
Australia
Phone 28098 0
+61 7 3176 5463
Fax 28098 0
Email 28098 0
[email protected]
Contact person for public queries
Name 11255 0
Mrs Alicia Morrish
Address 11255 0
Australasian Kidney Trials Network (UQ)
Ground Floor, Bldg 33
Princess Alexandra Hospital
199 Ipswich Road,
WOOLLOONGABBA QLD 4102
Country 11255 0
Australia
Phone 11255 0
+61 7 3443 5463
Fax 11255 0
07 3176 5663
Email 11255 0
[email protected]
Contact person for scientific queries
Name 2183 0
Prof David Johnson
Address 2183 0
Department of Nephrology, ARTS Building, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Brisbane 4102
Country 2183 0
Australia
Phone 2183 0
61 7 3240 5080
Fax 2183 0
61 7 3240 5480
Email 2183 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12353Statistical analysis plan https://aktn.org.au 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes http://dx.doi.org/10.1016/S1473-3099(13)70258-5 O... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe 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.2015https://dx.doi.org/10.3747/pdi.2014.00206
N.B. These documents automatically identified may not have been verified by the study sponsor.