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Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children.
J Infect Dis. 2012 Feb 15; 205(4):684-92.JI

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 = 58) or miltefosine (1.8-2.5 mg/kg/d for 28 days; by mouth) (n = 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.

CLINICAL TRIAL REGISTRATION

NCT00487253.

Authors+Show Affiliations

Centro Internacional De Entrenamiento E Investigaciones Médicas (CIDEIM), Cali, Colombia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22238470

Citation

Rubiano, Luisa Consuelo, et al. "Noninferiority of Miltefosine Versus Meglumine Antimoniate for Cutaneous Leishmaniasis in Children." The Journal of Infectious Diseases, vol. 205, no. 4, 2012, pp. 684-92.
Rubiano LC, Miranda MC, Muvdi Arenas S, et al. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. J Infect Dis. 2012;205(4):684-92.
Rubiano, L. C., Miranda, M. C., Muvdi Arenas, S., Montero, L. M., Rodríguez-Barraquer, I., Garcerant, D., Prager, M., Osorio, L., Rojas, M. X., Pérez, M., Nicholls, R. S., & Gore Saravia, N. (2012). Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. The Journal of Infectious Diseases, 205(4), 684-92. https://doi.org/10.1093/infdis/jir816
Rubiano LC, et al. Noninferiority of Miltefosine Versus Meglumine Antimoniate for Cutaneous Leishmaniasis in Children. J Infect Dis. 2012 Feb 15;205(4):684-92. PubMed PMID: 22238470.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. AU - Rubiano,Luisa Consuelo, AU - Miranda,María Consuelo, AU - Muvdi Arenas,Sandra, AU - Montero,Luz Mery, AU - Rodríguez-Barraquer,Isabel, AU - Garcerant,Daniel, AU - Prager,Martín, AU - Osorio,Lyda, AU - Rojas,Maria Ximena, AU - Pérez,Mauricio, AU - Nicholls,Ruben Santiago, AU - Gore Saravia,Nancy, Y1 - 2012/01/11/ PY - 2012/1/13/entrez PY - 2012/1/13/pubmed PY - 2012/3/16/medline SP - 684 EP - 92 JF - The Journal of infectious diseases JO - J Infect Dis VL - 205 IS - 4 N2 - 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 = 58) or miltefosine (1.8-2.5 mg/kg/d for 28 days; by mouth) (n = 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. CLINICAL TRIAL REGISTRATION: NCT00487253. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/22238470/Noninferiority_of_miltefosine_versus_meglumine_antimoniate_for_cutaneous_leishmaniasis_in_children_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jir816 DB - PRIME DP - Unbound Medicine ER -