Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India
Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2–11 years) with...
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| Veröffentlicht in: | Clinical infectious diseases 2004-01, Vol.38 (2), p.217-221 |
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| creator | Bhattacharya, Sujit K. Jha, T. K. Sundar, Shyam Thakur, C. P. Engel, Juergen Sindermann, Herbert Junge, Klaus Karbwang, Juntra Bryceson, Anthony D. M. Berman, Jonathan D. |
| description | Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2–11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in ∼25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India. |
| doi_str_mv | 10.1086/380638 |
| format | Article |
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K. ; Sundar, Shyam ; Thakur, C. P. ; Engel, Juergen ; Sindermann, Herbert ; Junge, Klaus ; Karbwang, Juntra ; Bryceson, Anthony D. M. ; Berman, Jonathan D.</creator><creatorcontrib>Bhattacharya, Sujit K. ; Jha, T. K. ; Sundar, Shyam ; Thakur, C. P. ; Engel, Juergen ; Sindermann, Herbert ; Junge, Klaus ; Karbwang, Juntra ; Bryceson, Anthony D. M. ; Berman, Jonathan D.</creatorcontrib><description>Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2–11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in ∼25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1086/380638</identifier><identifier>PMID: 14699453</identifier><identifier>CODEN: CIDIEL</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Adults ; Animals ; Antiprotozoal Agents - adverse effects ; Antiprotozoal Agents - therapeutic use ; aspartate aminotransferase ; Biological and medical sciences ; Child ; Child, Preschool ; Childhood ; Children ; Diarrhea ; Female ; Grade 1 ; Human protozoal diseases ; Humans ; Infectious diseases ; Leishmania ; Leishmaniasis, Visceral - drug therapy ; Leshmaniasis ; Major Articles ; Male ; Medical cures ; Medical sciences ; miltefosine ; Parasites ; Parasitic diseases ; Phosphorylcholine - adverse effects ; Phosphorylcholine - analogs & derivatives ; Phosphorylcholine - therapeutic use ; Protozoal diseases ; Relapse ; Treatment Outcome ; Visceral leishmaniasis ; Vomiting</subject><ispartof>Clinical infectious diseases, 2004-01, Vol.38 (2), p.217-221</ispartof><rights>Copyright 2004 The Infectious Diseases Society of America</rights><rights>2004 by the Infectious Diseases Society of America 2004</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c453t-6a785d6f574e659216756e25b4bc80c2d054bd4382909a1d53ef7f75953437be3</citedby><cites>FETCH-LOGICAL-c453t-6a785d6f574e659216756e25b4bc80c2d054bd4382909a1d53ef7f75953437be3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/4462749$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/4462749$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,803,27924,27925,58017,58250</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15707581$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14699453$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bhattacharya, Sujit K.</creatorcontrib><creatorcontrib>Jha, T. K.</creatorcontrib><creatorcontrib>Sundar, Shyam</creatorcontrib><creatorcontrib>Thakur, C. P.</creatorcontrib><creatorcontrib>Engel, Juergen</creatorcontrib><creatorcontrib>Sindermann, Herbert</creatorcontrib><creatorcontrib>Junge, Klaus</creatorcontrib><creatorcontrib>Karbwang, Juntra</creatorcontrib><creatorcontrib>Bryceson, Anthony D. M.</creatorcontrib><creatorcontrib>Berman, Jonathan D.</creatorcontrib><title>Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><addtitle>Clinical Infectious Diseases</addtitle><description>Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2–11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in ∼25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India.</description><subject>Adults</subject><subject>Animals</subject><subject>Antiprotozoal Agents - adverse effects</subject><subject>Antiprotozoal Agents - therapeutic use</subject><subject>aspartate aminotransferase</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Childhood</subject><subject>Children</subject><subject>Diarrhea</subject><subject>Female</subject><subject>Grade 1</subject><subject>Human protozoal diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Leishmania</subject><subject>Leishmaniasis, Visceral - drug therapy</subject><subject>Leshmaniasis</subject><subject>Major Articles</subject><subject>Male</subject><subject>Medical cures</subject><subject>Medical sciences</subject><subject>miltefosine</subject><subject>Parasites</subject><subject>Parasitic diseases</subject><subject>Phosphorylcholine - adverse effects</subject><subject>Phosphorylcholine - analogs & derivatives</subject><subject>Phosphorylcholine - therapeutic use</subject><subject>Protozoal diseases</subject><subject>Relapse</subject><subject>Treatment Outcome</subject><subject>Visceral leishmaniasis</subject><subject>Vomiting</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10MtqGzEUBmARUpo0bZ4gBHXR7qaVRvdlcXMDl9KQG9kIjS5YiTxypTHEb98JY-JVVxL8H-ccfgCOMfqGkeTfiUScyD1wiBkRDWcK749_xGRDJZEH4EOtTwhhLBF7Dw4w5UpRRg7B3VkI0Rq7gaZ38CYnX0wXUxw2MAf4K6bBh1xj72HIBc4WMblFzg7exWpHmuDcx7pYmj6aGiuMPbzqXTQfwbtgUvWftu8RuD0_u5ldNvPfF1ezH_PGjtuHhhshmeOBCerHm1vMBeO-ZR3trES2dYjRzlEiW4WUwY4RH0QQTDFCieg8OQJfp7mrkv-ufR308vWwlEzv87pqrFqipEQ7aEuutfigVyUuTdlojPRrg3pqcISn24nrbundjm0rG8GXLTDVmhSK6W2sO8cEEkzi0X2eXF6v_r_sZDJPdcjlTVHKW0HVGDdTHOvgX95iU541F0QwffnwqB_-_Lyf3V886mvyD_PemXs</recordid><startdate>20040115</startdate><enddate>20040115</enddate><creator>Bhattacharya, Sujit K.</creator><creator>Jha, T. 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M.</creatorcontrib><creatorcontrib>Berman, Jonathan D.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bhattacharya, Sujit K.</au><au>Jha, T. K.</au><au>Sundar, Shyam</au><au>Thakur, C. P.</au><au>Engel, Juergen</au><au>Sindermann, Herbert</au><au>Junge, Klaus</au><au>Karbwang, Juntra</au><au>Bryceson, Anthony D. M.</au><au>Berman, Jonathan D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India</atitle><jtitle>Clinical infectious diseases</jtitle><stitle>Clinical Infectious Diseases</stitle><addtitle>Clinical Infectious Diseases</addtitle><date>2004-01-15</date><risdate>2004</risdate><volume>38</volume><issue>2</issue><spage>217</spage><epage>221</epage><pages>217-221</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><coden>CIDIEL</coden><abstract>Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2–11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in ∼25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India.</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><pmid>14699453</pmid><doi>10.1086/380638</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adults Animals Antiprotozoal Agents - adverse effects Antiprotozoal Agents - therapeutic use aspartate aminotransferase Biological and medical sciences Child Child, Preschool Childhood Children Diarrhea Female Grade 1 Human protozoal diseases Humans Infectious diseases Leishmania Leishmaniasis, Visceral - drug therapy Leshmaniasis Major Articles Male Medical cures Medical sciences miltefosine Parasites Parasitic diseases Phosphorylcholine - adverse effects Phosphorylcholine - analogs & derivatives Phosphorylcholine - therapeutic use Protozoal diseases Relapse Treatment Outcome Visceral leishmaniasis Vomiting |
| title | Efficacy and Tolerability of Miltefosine for Childhood Visceral Leishmaniasis in India |
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