{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:36:17Z","timestamp":1792802177871,"version":"4.5.0"},"update-to":[{"DOI":"10.1371\/journal.pntd.0009069","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T00:00:00Z","timestamp":1614297600000}}],"reference-count":26,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2021,2,16]],"date-time":"2021-02-16T00:00:00Z","timestamp":1613433600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/publicdomain\/zero\/1.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPPGH5342"],"award-info":[{"award-number":["OPPGH5342"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Coalition for Operational Research, Neglected Tropical Diseases Support Centre, The Task Force for Global Health","id":[{"id":"https:\/\/ror.org\/03747hz63","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Eisai Co."},{"name":"Ministry of Health and Family Welfare, India","id":[{"id":"https:\/\/ror.org\/04pqetg36","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Better drug regimens for mass drug administration (MDA) could accelerate the Global Programme to Eliminate Lymphatic Filariasis (LF). This community study was designed to compare the safety and efficacy of MDA with IDA (ivermectin, diethylcarbamazine and albendazole) or DA (diethylcarbamazine and albendazole) in India.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methodology\/Principal findings<\/jats:title>\n                    <jats:p>This two-armed, open-labelled, block randomised, community study was conducted in LF endemic villages in Yadgir district, Karnataka, India. Consenting participants \u22655 years of age were tested for circulating filarial antigenemia (CFA) and microfilaremia (Mf) before treatment with a single oral dose of IDA or DA. Adverse events (AEs) were monitored actively for two days and passively for five more days. Persons with positive CFA or Mf tests at baseline were retested 12-months post-treatment to assess treatment efficacy.<\/jats:p>\n                    <jats:p>Baseline CFA and Mf-rates were 26.4% and 6.9% in IDA and 24.5% and 6.4% in DA villages respectively. 4758 and 4160 participants received IDA and DA. Most AEs were mild after both treatments; fewer than 0.1% of participants experienced AEs with severity &gt; grade 1. No serious AEs were observed. Fever, headache and dizziness were the most common AEs. AE rates were slightly higher after IDA than DA (8.3% vs. 6.4%, P&lt;0.01). AEs were more frequent in females and Mf-positives after either treatment, but significantly more frequent after IDA (40.5% vs 20.2%, P &lt; 0.001).<\/jats:p>\n                    <jats:p>IDA was more effective for clearing Mf than DA (84% vs. 61.8%, P &lt; 0.001). Geometric mean Mf counts per 60\u03bcl in retested Mf-positives decreased by 96.4% from 11.8 after IDA and by 90.0% from 9.5 after DA. Neither treatment was effective for clearing CFA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Conclusions\/Significance<\/jats:title>\n                    <jats:p>IDA had an acceptable safety profile and was more effective for clearing Mf than DA. With adequate compliance and medical support to manage AEs, IDA has the potential to accelerate LF elimination in India.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Clinical Trial Registry of India (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/CTRI No\/2016\/10\/007399\" xlink:type=\"simple\">CTRI No\/2016\/10\/007399<\/jats:ext-link>\n                      )\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pntd.0009069","type":"journal-article","created":{"date-parts":[[2021,2,16]],"date-time":"2021-02-16T17:22:25Z","timestamp":1613496145000},"page":"e0009069","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":40,"title":["An open label, block randomized, community study of the safety and efficacy of co-administered ivermectin, diethylcarbamazine plus albendazole vs. diethylcarbamazine plus albendazole for lymphatic filariasis in India"],"prefix":"10.1371","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0962-6953","authenticated-orcid":true,"given":"Purushothaman","family":"Jambulingam","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8435-218X","authenticated-orcid":true,"given":"Vijesh Sreedhar","family":"Kuttiatt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaliannagounder","family":"Krishnamoorthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0804-0763","authenticated-orcid":true,"given":"Swaminathan","family":"Subramanian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6105-4297","authenticated-orcid":true,"given":"Adinarayanan","family":"Srividya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hari Kishan K.","family":"Raju","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0932-0935","authenticated-orcid":true,"given":"Manju","family":"Rahi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8309-1304","authenticated-orcid":true,"given":"Roopali K.","family":"Somani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mallanna K.","family":"Suryaprakash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gangeshwar P.","family":"Dwivedi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6336-3824","authenticated-orcid":true,"given":"Gary J.","family":"Weil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2021,2,16]]},"reference":[{"issue":"44","key":"pntd.0009069.ref001","first-page":"589","article-title":"Global programme to eliminate lymphatic filariasis: progress report, 2017","volume":"91","author":"World Health Organization","year":"2018","journal-title":"Wkly Epidemiol Rec."},{"issue":"2","key":"pntd.0009069.ref002","first-page":"1","article-title":"Elimination of lymphatic filariasis\u2013India: Updates and way forward","volume":"3","author":"N. 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S. Common terminology criteria for adverse events (CTCAE). [cited 2018 Jun 8]. Available from: https:\/\/evsncinihgov\/ftp1\/CTCAE\/CTCAE_403\/CTCAE_403_2010-06-14_QuickReference_85x11pdf. 2009."},{"issue":"1","key":"pntd.0009069.ref021","doi-asserted-by":"crossref","first-page":"96","DOI":"10.4269\/ajtmh.19-0532","article-title":"Frequency and Clinical Significance of Localized Adverse Events following Mass Drug Administration for Lymphatic Filariasis in an Endemic Area in South India","volume":"102","author":"VS Kuttiatt","year":"2020","journal-title":"Am J Trop Med Hyg"},{"issue":"3","key":"pntd.0009069.ref022","doi-asserted-by":"crossref","first-page":"e0008106","DOI":"10.1371\/journal.pntd.0008106","article-title":"The safety of combined triple drug therapy with ivermectin, diethylcarbamazine and albendazole in the neglected tropical diseases co-endemic setting of Fiji: A cluster randomised trial","volume":"14","author":"M Hardy","year":"2020","journal-title":"PLoS Negl Trop Dis"},{"issue":"6","key":"pntd.0009069.ref023","doi-asserted-by":"crossref","first-page":"e0008298","DOI":"10.1371\/journal.pntd.0008298","article-title":"Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: results from a two-armed, open-label, cluster-randomized, community study2020","volume":"14","author":"CL Dubray","journal-title":"PLOS Neglected Tropical Diseases"},{"issue":"5","key":"pntd.0009069.ref024","doi-asserted-by":"crossref","first-page":"e0006454","DOI":"10.1371\/journal.pntd.0006454","article-title":"Adverse events following single dose treatment of lymphatic filariasis: Observations from a review of the literature","volume":"12","author":"PJ Budge","year":"2018","journal-title":"PLoS Negl Trop Dis"},{"issue":"20","key":"pntd.0009069.ref025","doi-asserted-by":"crossref","first-page":"1956","DOI":"10.1056\/NEJMc1914262","article-title":"Single-Dose Triple-Drug Therapy for Wuchereria bancrofti\u20145-Year Follow-up","volume":"382","author":"CL King","year":"2020","journal-title":"N Engl J Med"},{"key":"pntd.0009069.ref026","article-title":"Efficacy and safety of a single dose of ivermectin, diethylcarbamazine and albendazole for treatment of lymphatic filariasis in Cote d\u2019Ivoire: an open-label, randomized, controlled trial","author":"CM Bjerum","year":"2019","journal-title":"Clin Infect Dis"}],"updated-by":[{"DOI":"10.1371\/journal.pntd.0009069","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T00:00:00Z","timestamp":1614297600000}}],"container-title":["PLOS Neglected Tropical Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0009069","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T13:48:22Z","timestamp":1614347302000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0009069"}},"subtitle":[],"editor":[{"given":"Subash","family":"Babu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2021,2,16]]},"references-count":26,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2021,2,16]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pntd.0009069","relation":{},"ISSN":["1935-2735"],"issn-type":[{"value":"1935-2735","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,2,16]]}}}