Evidence map›Paper›PMID 36930667›Full record

Trial reportPLoS neglected tropical diseases2023

One versus two doses of ivermectin-based mass drug administration for the control of scabies: A cluster randomised non-inferiority trial.

Susanna J Lake, Daniel Engelman, Julie Zinihite, Oliver Sokana, Dickson Boara, Titus Nasi, Christina Gorae, Millicent H Osti, Sophie Phelan, Matthew Parnaby and 8 more

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS neglected tropical diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 4 countries.

Susanna J LakeTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.ORCID 0000-0002-5508-5430
Daniel EngelmanTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
Julie ZinihiteTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
Oliver SokanaMinistry of Health and Medical Services, Solomon Islands.
Dickson BoaraMinistry of Health and Medical Services, Solomon Islands.
Titus NasiMinistry of Health and Medical Services, Solomon Islands.
Christina GoraeMinistry of Health and Medical Services, Solomon Islands.
Millicent H OstiTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
Sophie PhelanKirby Institute, University of New South Wales, Sydney, Australia.
Matthew ParnabyTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
Anneke C GroblerClinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Australia.
Tibor SchusterDepartment of Family Medicine, McGill University, Montreal, Canada.
Ross AndrewsAustralian National University, Canberra, Australia.
Margot J WhitfeldDepartment of Dermatology, St Vincent's Hospital, Sydney, Australia.
Michael MarksClinic Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Lucia RomaniTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
Andrew C SteerTropical Diseases Research Group, Murdoch Children's Research Institute, Melbourne, Australia.
John M KaldorKirby Institute, University of New South Wales, Sydney, Australia.
Ministry of Health and Social Services · NAThe University of Melbourne · AUMurdoch Children's Research Institute · AUUNSW Sydney · AUAustralian National University · AUMcGill University · CARoyal London Hospital · GBSt Vincent's Hospital Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMass 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.

methodsRISE was a cluster-randomised trial in Solomon Islands. We assigned 20 villages in a 1:1 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.

resultsWe 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.

conclusionsThere 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 registrationRegistered with Australian New Zealand Clinical Trials Registry ACTRN12618001086257.

Indexed as

COVID-19ImpetigoScabiesAustraliaHumansIvermectinMass Drug AdministrationPandemicsIvermectin

Identifiers

PMID36930667
PMCPMC10058081
OpenAlexW4327676109

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.