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- Title
Noninferiority of Miltefosine Versus Meglumine Antimoniate for Cutaneous Leishmaniasis in Children.
- Authors
Rubiano, Luisa Consuelo; Miranda, María Consuelo; Arenas, Sandra Muvdi; Montero, Luz Mery; Rodríguez-Barraquer, Isabel; Garcerant, Daniel; Prager, Martín; Osorio, Lyda; Rojas, Maria Ximena; Pérez, Mauricio; Nicholls, Ruben Santiago; Saravia, Nancy Gore
- Abstract
Background. Children have a lower response rate to antimonial drugs and higher elimination rate of antimony (Sb) than adults. Oral miltefosine has not been evaluated for pediatric cutaneous leishmaniasis. Methods. A randomized, noninferiority clinical trial with masked evaluation was conducted at 3 locations in Colombia where Leishmania panamensis and Leishmania guyanensis predominated. One hundred sixteen children aged 2-12 years with parasitologically confirmed cutaneous leishmaniasis were randomized to directly observed treatment with meglumine antimoniate (20 mg Sb/kg/d for 20 days; intramuscular) (n 5 58) or miltefosine (1.8- 2.5 mg/kg/d for 28 days; by mouth) (n 5 58). Primary outcome was treatment failure at or before week 26 after initiation of treatment. Miltefosine was noninferior if the proportion of treatment failures was ≤15% higher than achieved with meglumine antimoniate (1-sided test, α = .05). Results. Ninety-five percent of children (111/116) completed follow-up evaluation. By intention-to-treat analysis, failure rate was 17.2% (98% confidence interval [CI], 5.7%-28.7%) for miltefosine and 31% (98% CI, 16.9%-45.2%) for meglumine antimoniate. The difference between treatment groups was 13.8%, (98% CI, -4.5% to 32%) (P = .04). Adverse events were mild for both treatments. Conclusions. Miltefosine is noninferior to meglumine antimoniate for treatment of pediatric cutaneous leishmaniasis caused by Leishmania (Viannia) species. Advantages of oral administration and low toxicity favor use of miltefosine in children.
- Subjects
THERAPEUTIC use of antimony; CUTANEOUS leishmaniasis; CLINICAL trials; CONFIDENCE intervals; ANTIPROTOZOAL agents; ALANINE aminotransferase; CREATININE
- Publication
Journal of Infectious Diseases, 2012, Vol 205, Issue 4, p684
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jir816