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Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo.

ABSTRACT: BACKGROUND:Scabies is a public health problem in many countries, with impetigo and its complications important consequences. Ivermectin based mass drug administration (MDA) reduces the prevalence of scabies and, to a lesser extent, impetigo. We studied the impact of co-administering azithromycin on the prevalence of impetigo and antimicrobial resistance. METHODS:Six communities were randomized to receive either ivermectin-based MDA or ivermectin-based MDA co-administered with azithromycin. We measured scabies and impetigo prevalence at baseline and 12 months. We collected impetigo lesions swabs at baseline, 3 and 12 months to detect antimicrobial resistance. RESULTS:At baseline, scabies and impetigo prevalences were 11.8% and 10.1% in the ivermectin-only arm and 9.2% and 12.1% in the combined treatment arm. At 12 months, the prevalences had fallen to 1.0% and 2.5% in the ivermectin-only arm and 0.7% and 3.3% in the combined treatment arm. The proportion of impetigo lesions containing Staphylococcus aureus detected did not change (80% at baseline vs 86% at 12 months; no significant difference between arms) but the proportion containing pyogenic streptococci fell significantly (63% vs 23%, P < .01). At 3 months, 53% (8/15) of S. aureus isolates were macrolide-resistant in the combined treatment arm, but no resistant strains (0/13) were detected at 12 months. CONCLUSIONS:Co-administration of azithromycin with ivermectin led to similar decreases in scabies and impetigo prevalence compared to ivermectin alone. The proportion of impetigo lesions containing pyogenic streptococci declined following MDA. There was a transient increase in the proportion of macrolide-resistant S. aureus strains following azithromycin MDA. CLINICAL TRIALS REGISTRATION:clinicaltrials.gov (NCT02775617).

SUBMITTER: Marks M

PROVIDER: S-EPMC6399435 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo.

Marks Michael M Toloka Hilary H Baker Ciara C Kositz Christian C Asugeni James J Puiahi Elliot E Asugeni Rowena R Azzopardi Kristy K Diau Jason J Kaldor John M JM Romani Lucia L Redman-MacLaren Michelle M MacLaren David D Solomon Anthony W AW Mabey David C W DCW Steer Andrew C AC

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20190301 6

<h4>Background</h4>Scabies is a public health problem in many countries, with impetigo and its complications important consequences. Ivermectin based mass drug administration (MDA) reduces the prevalence of scabies and, to a lesser extent, impetigo. We studied the impact of co-administering azithromycin on the prevalence of impetigo and antimicrobial resistance.<h4>Methods</h4>Six communities were randomized to receive either ivermectin-based MDA or ivermectin-based MDA co-administered with azit ...[more]

PMID: 29985978

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Project description:BackgroundIn small community-based trials, mass drug administration of ivermectin has been shown to substantially decrease the prevalence of both scabies and secondary impetigo; however, their effect at large scale is untested. Additionally, combined mass administration of drugs for two or more neglected diseases has potential practical advantages, but efficacy of potential combinations should be confirmed.MethodsThe azithromycin ivermectin mass drug administration (AIM) trial was a prospective, single-arm, before-and-after, community intervention study to assess the efficacy of mass drug administration of ivermectin for scabies and impetigo, with coadministration of azithromycin for trachoma. Mass drug administration was offered to the entire population of Choiseul Province, Solomon Islands, and of this population we randomly selected two sets of ten sentinel villages for monitoring, one at baseline and the other at 12 months. Participants were offered a single dose of 20 mg/kg azithromycin, using weight-based bands. Children weighing less than 12·5 kg received azithromycin oral suspension (20 mg/kg), and infants younger than 6 months received topical 1% tetracycline ointment. For ivermectin, participants were offered two doses of oral ivermectin 200 μg/kg 7-14 days apart using weight-based bands, or 5% permethrin cream 7-14 days apart if ivermectin was contraindicated. Our study had the primary outcomes of safety and feasibility of large-scale mass coadministration of oral ivermectin and azithromycin, which have been previously reported. We report here the prevalence of scabies and impetigo in residents of the ten baseline villages compared with those in the ten 12-month villages, as measured by examination of the skin, which was a secondary outcome of the trial. Further outcomes were comparison of the number of all-cause outpatient attendances at government clinics in Choiseul Province at various timepoints before and after mass drug administration. The trial was registered with the Australian and New Zealand Trials Registry (ACTRN12615001199505).FindingsDuring September, 2015, over 4 weeks, 26 188 people (99·3% of the estimated population of Choiseul [n=26 372] as determined at the 2009 census) were treated. At baseline, 1399 (84·2%) of 1662 people living in the first ten villages had their skin examined, of whom 261 (18·7%) had scabies and 347 (24·8%) had impetigo. At 12 months after mass drug administration, 1261 (77·6%) of 1625 people in the second set of ten villages had their skin examined, of whom 29 (2·3%) had scabies (relative reduction 88%, 95% CI 76·5-99·3) and 81 (6·4%) had impetigo (relative reduction 74%, 63·4-84·7). In the 3 months after mass drug administration, 10 614 attended outpatient clinics for any reason compared with 16 602 in the 3 months before administration (decrease of 36·1%, 95% CI 34·7-37·6), and during this period attendance for skin sores, boils, and abscesses decreased by 50·9% (95% CI 48·6-53·1).InterpretationIvermectin-based mass drug administration can be scaled to a population of over 25 000 with high efficacy and this level of efficacy can be achieved when mass drug administration for scabies is integrated with mass drug administration of azithromycin for trachoma. These findings will contribute to development of population-level control strategies. Further research is needed to assess durability and scalability of mass drug administration in larger, non-island populations, and to assess its effect on the severe bacterial complications of scabies.FundingInternational Trachoma Initiative, Murdoch Children's Research Institute, Scobie and Claire Mackinnon Trust, and the Wellcome Trust.

Project description:IntroductionScabies is recognised as a neglected tropical disease, disproportionately affecting the most vulnerable populations around the world. Impetigo often occurs secondarily to scabies. Several studies have explored mass drug administration (MDA) programmes, with some showing positive outcomes-but a systematic evaluation of such studies is yet to be reported. The main aim of this systematic review is to generate comprehensive evidence on the effect and feasibility of MDA programmes in reducing the burden of scabies and impetigo.Methods and analysisA systematic review and meta-analysis will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Electronic databases to be searched will include CINAHL EBSCOhost, Medline Ovid, ProQuest, Science Direct, PubMed and SCOPUS. In addition, grey literature will be explored via the Australian Institute of Health and Welfare, Australian Indigenous HealthInfoNet, Informit, OaIster database and WHO. No language restrictions will be applied. All treatment studies following an MDA protocol, including randomised/quasi-controlled trials, and prospective before-after interventional studies, will be considered. The main outcome is the change in prevalence of scabies and impetigo The Cochrane collaboration risk of bias assessment tool will be used for assessing the methodological quality of studies. A random-effect restricted maximum likelihood meta-analysis will be performed to generate pooled effect (OR) using STATA V.16. Appropriate statistical tests will be carried out to quantify heterogeneity between studies and publication bias.Ethics and disseminationEthical approval is not required since data will be extracted from published works. The findings will be communicated to the scientific community through a peer-reviewed journal publication. This systematic review will present an evidence on the effect of MDA interventions on scabies and impetigo, which is instrumental to obtain a clear understanding of the treatments widely used in these programmes.Prospero registration numberCRD42020169544.

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Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo.

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Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo.

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