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One versus two doses of ivermectin-based mass drug administration for the control of scabies: A cluster randomised non-inferiority trial.
Lake, Susanna J; Engelman, Daniel; Zinihite, Julie; Sokana, Oliver; Boara, Dickson; Nasi, Titus; Gorae, Christina; Osti, Millicent H; Phelan, Sophie; Parnaby, Matthew; Grobler, Anneke C; Schuster, Tibor; Andrews, Ross; Whitfeld, Margot J; Marks, Michael; Romani, Lucia; Steer, Andrew C; Kaldor, John M.
  • Lake SJ; Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
  • Engelman D; Department of Paediatrics, University of Melbourne, Melbourne, Australia.
  • Zinihite J; Melbourne Children's Global Health, Melbourne, Australia.
  • Sokana O; Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
  • Boara D; Department of Paediatrics, University of Melbourne, Melbourne, Australia.
  • Nasi T; Melbourne Children's Global Health, Melbourne, Australia.
  • Gorae C; Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
  • Osti MH; Ministry of Health and Medical Services, Solomon Islands.
  • Phelan S; Ministry of Health and Medical Services, Solomon Islands.
  • Parnaby M; Ministry of Health and Medical Services, Solomon Islands.
  • Grobler AC; Ministry of Health and Medical Services, Solomon Islands.
  • Schuster T; Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
  • Andrews R; Department of Paediatrics, University of Melbourne, Melbourne, Australia.
  • Whitfeld MJ; Kirby Institute, University of New South Wales, Sydney, Australia.
  • Marks M; Tropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
  • Romani L; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Australia.
  • Steer AC; Department of Family Medicine, McGill University, Montreal, Canada.
  • Kaldor JM; Australian National University, Canberra, Australia.
PLoS Negl Trop Dis ; 17(3): e0011207, 2023 03.
Article in English | MEDLINE | ID: covidwho-2267825
ABSTRACT

BACKGROUND:

Mass drug administration (MDA) based on two doses of ivermectin, one week apart, substantially reduces prevalence of both scabies and impetigo. The Regimens of Ivermectin for Scabies Elimination (RISE) trial assessed whether one-dose ivermectin-based MDA would be as effective.

METHODS:

RISE was a cluster-randomised trial in Solomon Islands. We assigned 20 villages in a 11 ratio to one- or two-dose ivermectin-based MDA. We planned to test whether the impact of one dose on scabies prevalence at 12 and 24 months was non-inferior to two, at a 5% non-inferiority margin.

RESULTS:

We deferred endpoint assessment to 21 months due to COVID-19. We enrolled 5239 participants in 20 villages at baseline and 3369 at 21 months from an estimated population of 5500. At baseline scabies prevalence was similar in the two arms (one-dose 17·2%; two-dose 13·2%). At 21 months, there was no reduction in scabies prevalence (one-dose 18·7%; two-dose 13·4%), and the confidence interval around the difference included values substantially greater than 5%. There was however a reduction in prevalence among those who had been present at the baseline assessment (one-dose 15·9%; two-dose 10·8%). Additionally, we found a reduction in both scabies severity and impetigo prevalence in both arms, to a similar degree.

CONCLUSIONS:

There was no indication of an overall decline in scabies prevalence in either arm. The reduction in scabies prevalence in those present at baseline suggests that the unexpectedly high influx of people into the trial villages, likely related to the COVID-19 pandemic, may have compromised the effectiveness of the MDA. Despite the lack of effect there are important lessons to be learnt from this trial about conducting MDA for scabies in high prevalence settings. TRIAL REGISTRATION Registered with Australian New Zealand Clinical Trials Registry ACTRN12618001086257.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Scabies / COVID-19 / Impetigo Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Country/Region as subject: Oceania Language: English Journal: PLoS Negl Trop Dis Journal subject: Tropical Medicine Year: 2023 Document Type: Article Affiliation country: Journal.pntd.0011207

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Scabies / COVID-19 / Impetigo Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Country/Region as subject: Oceania Language: English Journal: PLoS Negl Trop Dis Journal subject: Tropical Medicine Year: 2023 Document Type: Article Affiliation country: Journal.pntd.0011207