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Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial

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  • معلومة اضافية
    • Contributors:
      Hôpital Pellegrin; Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)-Groupe hospitalier Pellegrin; Hôpital Henri Mondor; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Henri Mondor Créteil; Groupe Henri Mondor-Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Henri Mondor-Albert Chenevier-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12); Centre Hospitalier Universitaire de Nice (CHU Nice); Centre Hospitalier Chalon-sur-Saône William Morey (CH Chalon-sur-Saône); Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); Hospices Civils de Lyon (HCL); methodS in Patients-centered outcomes and HEalth ResEarch (SPHERE); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR des Sciences Pharmaceutiques et Biologiques (Nantes Univ - UFR Pharmacie); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Centre d’Investigation Clinique CHRU Tours (CIC 1415); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Hôpital universitaire Robert Debré Reims (CHU Reims); Hôpital Morvan - CHRU de Brest (CHU - BREST); CHU de Bordeaux Pellegrin Bordeaux; Service de dermatologie, vénéreologie et cancérologie cutanée Hôpital de la Timone - APHM; Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Timone CHU - APHM (TIMONE); Centre Hospitalier Intercommunal Fréjus - St Raphaël (CHI Fréjus - St Raphaël); CHU Rouen; Normandie Université (NU); Hôpital Avicenne AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre Hospitalier Le Mans (CH Le Mans); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); AP-HP Hôpital universitaire Robert-Debré Paris; Hopital Saint-Louis AP-HP (AP-HP); CENTRE HOSPITALIER PÉRIGUEUX (CHP); CHU Sud Saint Pierre Ile de la Réunion; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); Centre Hospitalier de Basse-Terre Guadeloupe; Hôpital Cochin AP-HP; Hôpital Saint-André Bordeaux; Centre Hospitalier Intercommunal de Créteil (CHIC)
    • بيانات النشر:
      CCSD
      BMJ
    • الموضوع:
      2026
    • Collection:
      Hospices Civils de Lyon (HCL): HAL
    • نبذة مختصرة :
      International audience ; Objective: To investigate whether oral ivermectin or topical 5% permethrin can clinically cure scabies in index cases and in members of their households.Design: Multicentre, assessor blinded, cluster randomised clinical trial.Setting: 28 French hospitals, 19 January 2016 to 16 December 2021.Participants: Index cases; adults and children weighing >15 kg with scabies, confirmed by dermoscopy.Interventions: Index cases were randomly assigned to the ivermectin group or permethrin group (1:1 ratio). Each member of the cluster, defined as the household of each index case, received the same treatment as the index case, except for children weighing <15 kg who were prescribed topical 5% permethrin. All participants received oral ivermectin 200 µg/kg or 5% permethrin cream on day 0 and day 10. Permethrin cream was applied to the whole body, from head to toe.Main outcome measures: The primary outcome was clinical cure of the cluster on day 28 (ie, disappearance of clinical signs and symptoms of scabies for all cluster members). Secondary outcomes were index case and individual level analyses and safety. Dermatologists were used as assessors and were masked to the treatment.Results: 507 participants in 142 households (clusters) were treated with ivermectin and 568 participants in 147 households received permethrin. Cluster level cure rates were 71.8% versus 88.5% (-16.7 percentage point difference, 95% confidence interval (CI) -26.3 to -7.1) for ivermectin versus permethrin. Secondary outcome percentage point differences also showed the inferiority of ivermectin compared with 5% permethrin for index cases (76.6% v 91.5%; percentage point difference -14.9, 95% CI -23.6 to -6.2) and participants (85.3% v 94.2%; -9.2 percentage point difference, -14.9 to -3.5). Intraclass correlation coefficients were higher for permethrin than ivermectin for all clusters (0.68, 95% CI 0.61 to 0.75 v 0.46, 0.37 to 0.56) and for cluster size >1 (0.67, 0.60 to 0.74 v 0.47, 0.37 to 0.56). Cutaneous adverse events ...
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/41494769; PUBMED: 41494769; PUBMEDCENTRAL: PMC12771274
    • الرقم المعرف:
      10.1136/bmj-2025-086277
    • الدخول الالكتروني :
      https://hal.science/hal-05529976
      https://hal.science/hal-05529976v1/document
      https://hal.science/hal-05529976v1/file/bmj-2025-086277.full.pdf
      https://doi.org/10.1136/bmj-2025-086277
    • Rights:
      https://creativecommons.org/licenses/by-nc/4.0/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.36394F8C