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Both the immature and adult stages of<jats:italic>A. caninum<\/jats:italic>ingest large volumes of blood during the feeding process and can cause severe anemia and death in young dogs, even before patent infections can be diagnosed using routine faecal examination methods. Thus, effective treatment of any pre-patent stages of immature hookworms can reduce or eliminate the risk of clinical disease in infected dogs and additionally reduce environmental contamination of eggs and infective larvae. Two randomized, blinded, GCP-compliant, pivotal laboratory dose confirmation studies were conducted to evaluate the effectiveness and safety of a new novel combination of lotilaner and milbemycin oxime tablets (Credelio Plus<jats:sup>\u00ae<\/jats:sup>) administered orally to dogs experimentally infected with immature (L4 and immature adult [L5]) stages of<jats:italic>A. caninum.<\/jats:italic><\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Treatments using the intended global commercial tablet formulation of Credelio Plus were administered in a time frame relative to inoculation with infective larvae so that effectiveness could be assessed against each specific immature stage of<jats:italic>A. caninum<\/jats:italic>. In each study, dogs were randomized to one of six (study 1) or four (study 2) treatment groups. Each treatment group contained 8 (study 1) or 10 (study 2) dogs that had been experimentally inoculated with infective<jats:italic>A. caninum<\/jats:italic>larvae on day 0 and were dosed once on day 7 or day 11. Enrolled subjects were administered placebo tablets, Credelio Plus tablets, or lotilaner mono tablets to provide minimum dosages of 0.75 mg\/kg of milbemycin oxime and 20 mg\/kg of lotilaner. All dogs were necropsied 5 days after their respective treatment. All nematodes recovered from the gastrointestinal tract at necropsy were counted by species and stage.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For both dose confirmation studies and based on geometric mean worm counts, efficacy of Credelio Plus was\u2009\u2265\u200997.3% against L4 larval stage of<jats:italic>A. caninum<\/jats:italic>and\u2009\u2265\u200998.7% against immature adult (L5)<jats:italic>A. caninum<\/jats:italic>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These studies demonstrated that the orally administered Credelio Plus combination tablet was highly efficacious in treating immature (L4 and immature adult [L5]) stages of<jats:italic>A. caninum<\/jats:italic>in experimentally infected dogs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Graphical Abstract<\/jats:title><\/jats:sec>","DOI":"10.1186\/s13071-021-04761-y","type":"journal-article","created":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T08:02:40Z","timestamp":1621238560000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Effectiveness of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio\u00ae Plus) for the treatment of larval and immature adult stages of Ancylostoma caninum in experimentally infected dogs"],"prefix":"10.1186","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4091-6297","authenticated-orcid":false,"given":"Daniel E.","family":"Snyder","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott","family":"Wiseman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Crawley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Wallace","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dwight D.","family":"Bowman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig R.","family":"Reinemeyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,5,17]]},"reference":[{"key":"4761_CR1","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1016\/j.vetpar.2006.11.013","volume":"145","author":"E Grandemange","year":"2007","unstructured":"Grandemange E, Claerebout E, Genchi C, Franc M. 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DES, SW, EC, and KW are current or former employees of Elanco Animal Health. DDB and CRR contracted as the study investigator and\/or the contracted veterinary parasitologist for each laboratory study. The handling editors have been involved in consulting services (Filipe Dantas-Torres), research projects (Filipe Dantas-Torres, Adnan Hod\u017eic) and meetings (Filipe Dantas-Torres) sponsored by different veterinary pharmaceutical companies in the past 10 years, including Elanco. They declare that each manuscript in this collection was handled impartially and peer reviewed rigorously by at least two independent external reviewers.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"255"}}