{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T02:52:35Z","timestamp":1791514355597,"version":"4.3.4"},"reference-count":0,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2020,8,20]],"date-time":"2020-08-20T00:00:00Z","timestamp":1597881600000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Pharmacokinetic data are a pre-requisite to integrated implementation of large-scale mass drug administration (MDA) for neglected tropical diseases (NTDs). We investigated the safety and drug interactions of a combination of azithromycin (AZI) targeting yaws and trachoma, with the newly approved ivermectin, albendazole, diethylcarbamazine (IDA) regime for Lymphatic Filariasis.<\/jats:p>\n <\/jats:sec>\n \n Methodology<\/jats:title>\n An open-label, randomized, 3-arm pharmacokinetic interaction study in adult volunteers was carried out in Lihir Island, Papua New Guinea. Healthy adult participants were recruited and randomized to (I) IDA alone, (II) IDA combined with AZI, (III) AZI alone. The primary outcome was lack of a clinically relevant drug interaction. The secondary outcome was the overall difference in the proportion of AEs between treatment arms.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Thirty-seven participants, eighteen men and nineteen women, were randomized and completed the study. There were no significant drug-drug interactions between the study arms. The GMR of Cmax, AUC0\u2013t, and AUC0\u2013\u221e for IVM, DEC, ALB-SOX, and AZI were within the range of 80\u2013125% (GMR for AUC0\u2013\u221e for IVM, 87.9; DEC, 92.9; ALB-SOX, 100.0; and AZI, 100.1). There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9\/12 (75%), co-administration arm 12\/13 (92%); p = 0.44). All AEs were grade 1 and self-limiting.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Co-administration of AZI with IDA did not show evidence of significant drug-interactions. There were no serious AEs in any of the study arms. Our data support further evaluation of the safety of integrated MDA for NTDs.<\/jats:p>\n Clinical Trials Registration. NCT03664063<\/jats:p>\n <\/jats:sec>","DOI":"10.1093\/cid\/ciaa1202","type":"journal-article","created":{"date-parts":[[2020,8,18]],"date-time":"2020-08-18T11:57:13Z","timestamp":1597751833000},"source":"Crossref","is-referenced-by-count":8,"title":["Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases"],"prefix":"10.1093","author":[{"given":"Lucy N","family":"John","sequence":"first","affiliation":[{"name":"National Department of Health, Port Moresby , Papua New Guinea"},{"name":"Barcelona Institute for Global Health - University of Barcelona, Barcelona ,","place":["Spain"]},{"name":"School of Medicine and Health Sciences, University of Papua New Guinea , Port Moresby, Papua New Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Bjerum","sequence":"additional","affiliation":[{"name":"Case Western Reserve University School of Medicine and Veterans Affairs Medical Center, Cleveland, OH ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pere Millat","family":"Martinez","sequence":"additional","affiliation":[{"name":"Lihir Malaria Elimination Program, Newcrest Lihir , New Ireland Province, Papua New Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rhoda","family":"Likia","sequence":"additional","affiliation":[{"name":"Lihir Malaria Elimination Program, Newcrest Lihir , New Ireland Province, Papua New Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Silus","sequence":"additional","affiliation":[{"name":"Lihir Malaria Elimination Program, Newcrest Lihir , New Ireland Province, Papua New Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chilaka","family":"Wali","sequence":"additional","affiliation":[{"name":"Barcelona Institute for Global Health - University of Barcelona, Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Elizah","sequence":"additional","affiliation":[{"name":"Lihir Malaria Elimination Program, Newcrest Lihir , New Ireland Province, Papua New Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yashpal S","family":"Chhonker","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Laboratory, Dept. of Pharmacy Practice and Science, Nebraska University Medical Center , Omaha, NE,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veenu","family":"Bala","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Laboratory, Dept. of Pharmacy Practice and Science, Nebraska University Medical Center , Omaha, NE,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher L","family":"King","sequence":"additional","affiliation":[{"name":"Case Western Reserve University School of Medicine and Veterans Affairs Medical Center, Cleveland, OH ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daryl J","family":"Murry","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Laboratory, Dept. of Pharmacy Practice and Science, Nebraska University Medical Center , Omaha, NE,","place":["United States"]},{"name":"Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha , NE,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oriol","family":"Mitja","sequence":"additional","affiliation":[{"name":"Barcelona Institute for Global Health - University of Barcelona, Barcelona ,","place":["Spain"]},{"name":"School of Medicine and Health Sciences, University of Papua New Guinea , Port Moresby, Papua New Guinea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Marks","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine, London, United Kingdom"},{"name":"Hospital for Tropical Diseases , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,8,20]]},"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciaa1202\/33669249\/ciaa1202.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciaa1202\/33669249\/ciaa1202.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,14]],"date-time":"2024-11-14T12:34:58Z","timestamp":1731587698000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/advance-article\/doi\/10.1093\/cid\/ciaa1202\/5895050"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,20]]},"references-count":0,"URL":"https:\/\/doi.org\/10.1093\/cid\/ciaa1202","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,20]]},"article-number":"ciaa1202"}}