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Sixty patients, 30 children aged 2 to 12 years and 30 adults aged 18 to 60 years, were enrolled. Participants received miltefosine (Impavido) at a nominal dose of 2.5 mg\/kg\/day for 28 days. Miltefosine concentrations were measured in plasma and peripheral blood mononuclear cells by liquid chromatography-tandem mass spectrometry of samples obtained during treatment and up to 6 months following completion of treatment, when therapeutic outcome was determined. Fifty-two patients were cured, 5 pediatric patients failed treatment, and 3 participants were lost to follow-up.\n            <jats:named-content content-type=\"genus-species\">Leishmania<\/jats:named-content>\n            (\n            <jats:named-content content-type=\"genus-species\">Viannia<\/jats:named-content>\n            )\n            <jats:named-content content-type=\"genus-species\">panamensis<\/jats:named-content>\n            predominated among the strains isolated (42\/46; 91%). Noncompartmental analysis demonstrated that plasma and intracellular miltefosine concentrations were, overall, lower in children than in adults. Exposure to miltefosine, estimated by area under the concentration-time curve and maximum concentration, was significantly lower in children in both the central and intracellular compartments (\n            <jats:italic>P<\/jats:italic>\n            &lt; 0.01).\n            <jats:named-content content-type=\"genus-species\">Leishmania<\/jats:named-content>\n            persistence was detected in 43% of study participants at the end of treatment and in 27% at 90 days after initiation of treatment. Clinical response was not dependent on parasite elimination.\n            <jats:italic>In vitro<\/jats:italic>\n            miltefosine susceptibility was similar for\n            <jats:named-content content-type=\"genus-species\">Leishmania<\/jats:named-content>\n            strains from adults and children. Our results document PK differences for miltefosine in children and adults with cutaneous leishmaniasis that affect drug exposure and could influence the outcome of treatment, and they provide bases for optimizing therapeutic regimens for CL in pediatric populations. (This study has been registered at ClinicalTrials.gov under identifier NCT01462500.)\n          <\/jats:p>","DOI":"10.1128\/aac.02198-16","type":"journal-article","created":{"date-parts":[[2016,12,13]],"date-time":"2016-12-13T02:30:41Z","timestamp":1481596241000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":44,"title":["Pharmacokinetics of Miltefosine in Children and Adults with Cutaneous Leishmaniasis"],"prefix":"10.1128","volume":"61","author":[{"given":"Mar\u00eda del Mar","family":"Castro","sequence":"first","affiliation":[{"name":"Centro Internacional de Entrenamiento e Investigaciones M\u00e9dicas, Cali, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Adelaida","family":"Gomez","sequence":"additional","affiliation":[{"name":"Centro Internacional de Entrenamiento e Investigaciones M\u00e9dicas, Cali, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anke E.","family":"Kip","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology &amp; Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands"},{"name":"Department of Pharmacy &amp; Pharmacology, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Cossio","sequence":"additional","affiliation":[{"name":"Centro Internacional de Entrenamiento e Investigaciones M\u00e9dicas, Cali, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Centro Internacional de Entrenamiento e Investigaciones M\u00e9dicas, Cali, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana","family":"Navas","sequence":"additional","affiliation":[{"name":"Centro Internacional de Entrenamiento e Investigaciones M\u00e9dicas, Cali, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas P. 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