Samir Benkouiten1, Rezak Drali2, Sékéné Badiaga3, Aurélie Veracx1, Roch Giorgi4, Didier Raoult1, Philippe Brouqui1. 1. Unité de Recherche sur les Maladies Infectieuses et Tropicales Émergentes, Aix-Marseille Université, Marseille, France2Institut Hospitalo-Universitaire Méditerranée Infection, Marseille, France. 2. Unité de Recherche sur les Maladies Infectieuses et Tropicales Émergentes, Aix-Marseille Université, Marseille, France2Institut Hospitalo-Universitaire Méditerranée Infection, Marseille, France3Service des Entérobactéries et Hygiène de l'Environnement, In. 3. Unité de Recherche sur les Maladies Infectieuses et Tropicales Émergentes, Aix-Marseille Université, Marseille, France. 4. Institut Hospitalo-Universitaire Méditerranée Infection, Marseille, France4Institut National de la Santé et de la Recherche Médicale, Aix-Marseille Université, Marseille, France.
Abstract
IMPORTANCE: The control of body lice in homeless persons remains a challenge. OBJECTIVE: To determine whether the use of long-lasting insecticide-treated underwear provides effective long-term protection against body lice in homeless persons. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial was conducted in February and December 2011 in 2 homeless shelters (Madrague Ville and Forbin) in Marseille, France. Of the 125 homeless persons screened for eligibility, 73 body lice-infested homeless persons, 18 years or older, were enrolled. INTERVENTIONS:Body lice-infested homeless persons were randomly assigned to receive 0.4% permethrin-impregnated underwear or an identical-appearing placebo for 45 days, in a 1:1 ratio, with a permuted block size of 10. Visits were scheduled at days 14 and 45. Data regarding the presence or absence of live body lice were collected. MAIN OUTCOMES AND MEASURES: The primary and secondary end points were the proportions of homeless persons free of body lice on days 14 and 45, respectively. Mutations associated with permethrin resistance in the body lice were also identified. RESULTS: Significantly more homeless persons receiving permethrin-impregnated underwear than homeless persons receiving theplacebo were free of body lice on day 14 in the intent-to-treat population (28% vs 9%; P = .04), with a between-group difference of 18.4 percentage points (95% CI, 1.4-35.4), and in the per-protocol population (34% vs 11%; P = .03), with a between-group difference of 23.7 percentage points (95% CI, 3.6-43.7). This difference was not sustained on day 45. At baseline, the prevalence of the permethrin-resistant haplotype was 51% in the permethrin group and 44% in the placebo group. On day 45, the permethrin-resistant haplotype was significantly more frequent in the permethrin group than in the placebo group (73% vs 45%, P < .001). CONCLUSION AND RELEVANCE: Permethrin-impregnated underwear is more efficient than placebo at eliminating body louse infestations by day 14; however, this difference was not sustained on day 45. The use of permethrin may have increased the resistance to permethrin in body lice and thus must be avoided. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01287663.
RCT Entities:
IMPORTANCE: The control of body lice in homeless persons remains a challenge. OBJECTIVE: To determine whether the use of long-lasting insecticide-treated underwear provides effective long-term protection against body lice in homeless persons. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial was conducted in February and December 2011 in 2 homeless shelters (Madrague Ville and Forbin) in Marseille, France. Of the 125 homeless persons screened for eligibility, 73 body lice-infested homeless persons, 18 years or older, were enrolled. INTERVENTIONS:Body lice-infested homeless persons were randomly assigned to receive 0.4% permethrin-impregnated underwear or an identical-appearing placebo for 45 days, in a 1:1 ratio, with a permuted block size of 10. Visits were scheduled at days 14 and 45. Data regarding the presence or absence of live body lice were collected. MAIN OUTCOMES AND MEASURES: The primary and secondary end points were the proportions of homeless persons free of body lice on days 14 and 45, respectively. Mutations associated with permethrin resistance in the body lice were also identified. RESULTS: Significantly more homeless persons receiving permethrin-impregnated underwear than homeless persons receiving the placebo were free of body lice on day 14 in the intent-to-treat population (28% vs 9%; P = .04), with a between-group difference of 18.4 percentage points (95% CI, 1.4-35.4), and in the per-protocol population (34% vs 11%; P = .03), with a between-group difference of 23.7 percentage points (95% CI, 3.6-43.7). This difference was not sustained on day 45. At baseline, the prevalence of the permethrin-resistant haplotype was 51% in the permethrin group and 44% in the placebo group. On day 45, the permethrin-resistant haplotype was significantly more frequent in the permethrin group than in the placebo group (73% vs 45%, P < .001). CONCLUSION AND RELEVANCE: Permethrin-impregnated underwear is more efficient than placebo at eliminating body louse infestations by day 14; however, this difference was not sustained on day 45. The use of permethrin may have increased the resistance to permethrin in body lice and thus must be avoided. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01287663.