title: Antibacterial honey for the prevention of peritoneal-dialysis-related infections (HONEYPOT): a randomised trial.
abstract: BACKGROUND
  There is a paucity of evidence to guide the best strategy for prevention of peritoneal-dialysis-related infections. Antibacterial honey has shown promise as a novel, cheap, effective, topical prophylactic agent without inducing microbial resistance. We therefore assessed whether daily application of honey at the exit site would increase the time to peritoneal-dialysis-related infections compared with standard exit-site care plus intranasal mupirocin prophylaxis for nasal carriers of Staphylococcus aureus.
  
  
  METHODS
  In this open-label trial undertaken in 26 centres in Australia and New Zealand, participants undergoing peritoneal dialysis were randomly assigned in a 1:1 ratio with an adaptive allocation algorithm to daily topical exit-site application of antibacterial honey plus standard exit-site care or intranasal mupirocin prophylaxis (only in carriers of nasal S aureus) plus standard exit-site care (control group). The primary endpoint was time to first infection related to peritoneal dialysis (exit-site infection, tunnel infection, or peritonitis). The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12607000537459.
  
  
  RESULTS
  Of 371 participants, 186 were assigned to the honey group and 185 to the control group. The median peritoneal-dialysis-related infection-free survival times were not significantly different in the honey (16·0 months [IQR not estimable]) and control groups (17·7 months [not estimable]; unadjusted hazard ratio 1·12, 95% CI 0·83-1·51; p=0·47). In the subgroup analyses, honey increased the risks of both the primary endpoint (1·85, 1·05-3·24; p=0·03) and peritonitis (2·25, 1·16-4·36) in participants with diabetes. The incidences of serious adverse events (298 vs 327, respectively; p=0·1) and deaths (14 vs 18, respectively; p=0·9) were not significantly different in the honey and control groups. 11 (6%) participants in the honey group had local skin reactions.
  
  
  CONCLUSIONS
  The findings of this trial show that honey cannot be recommended routinely for the prevention of peritoneal-dialysis-related infections.
  
  
  BACKGROUND
  Baxter Healthcare, Queensland Government, Comvita, and Gambro.
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia; Translational Research Institute, Brisbane, QLD, Australia. Electronic address: david_johnson@health.qld.gov.au.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Badve
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia.
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Pascoe
authors.affiliation: Centre for Research in Evidence-Based Practice, Bond University, Gold Coast, QLD, Australia.
authors.forename: Elaine
authors.initials: E
authors.lastname: Beller
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Menzies School of Health Research, Darwin, NT, Australia.
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Nambour Hospital, Nambour, QLD, Australia.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Clark
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Renal Medicine, North Shore Hospital, Auckland, New Zealand.
authors.forename: Janak
authors.initials: J
authors.lastname: de Zoysa
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Isbel
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Child and Adolescent Renal Service, Royal Children's and Mater Children's Hospitals, Brisbane, QLD, Australia.
authors.forename: Steven
authors.initials: S
authors.lastname: McTaggart
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia.
authors.forename: Alicia T
authors.initials: AT
authors.lastname: Morrish
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Infection Management Services, Princess Alexandra Hospital, Brisbane, QLD, Australia.
authors.forename: E Geoffrey
authors.initials: EG
authors.lastname: Playford
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia.
authors.forename: Anish
authors.initials: A
authors.lastname: Scaria
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Snelling
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia.
authors.forename: Liza A
authors.initials: LA
authors.lastname: Vergara
authors.affiliation: Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
authors.forename: Carmel M
authors.initials: CM
authors.lastname: Hawley
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001315:Australia; D001424:Bacterial Infections / Q000517:prevention & control*; D002353:Carrier State / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D005260:Female; D006722:Honey; D006801:Humans; D008297:Male; D008875:Middle Aged; D016712:Mupirocin / Q000008:administration & dosage; D009520:New Zealand; D010530:Peritoneal Dialysis / Q000009:adverse effects*; D010538:Peritonitis / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D016712:Mupirocin