title: Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India.
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 approximately 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.
authors.affiliation: Rajendra Memorial Research Institute of Medical Sciences, Agamkuan, India. JBe9320457@aol.com
authors.forename: Sujit K
authors.initials: SK
authors.lastname: Bhattacharya
authors.forename: T K
authors.initials: TK
authors.lastname: Jha
authors.forename: Shyam
authors.initials: S
authors.lastname: Sundar
authors.forename: C P
authors.initials: CP
authors.lastname: Thakur
authors.forename: Juergen
authors.initials: J
authors.lastname: Engel
authors.forename: Herbert
authors.initials: H
authors.lastname: Sindermann
authors.forename: Klaus
authors.initials: K
authors.lastname: Junge
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang
authors.forename: Anthony D M
authors.initials: AD
authors.lastname: Bryceson
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Berman
mesh_terms: D000818:Animals; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D010767:Phosphorylcholine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine