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.
Subject(s)
Antiprotozoal Agents/administration & dosage , Leishmania/isolation & purification , Leishmaniasis, Cutaneous/drug therapy , Meglumine/administration & dosage , Organometallic Compounds/administration & dosage , Phosphorylcholine/analogs & derivatives , Administration, Oral , Antiprotozoal Agents/adverse effects , Child , Child, Preschool , Colombia , Female , Humans , Male , Meglumine/adverse effects , Meglumine Antimoniate , Organometallic Compounds/adverse effects , Phosphorylcholine/administration & dosage , Phosphorylcholine/adverse effects , Treatment FailureABSTRACT
An open label, comparative study to compare the efficacy of thermotherapy to meglumine antimoniate in treating cutaneous leishmaniasis patients in an operational context was carried out in Chaparral, Colombia. After enrollment patients were followed-up for up to 100 days. Per protocol and intention-to-treat cure rates for 47 patients treated using thermotherapy (one-time 50 degrees C applications for 30s) were 100 and 19%, respectively. Per protocol and intention-to-treat cure rates for meglumine antimoniate (20 mg/kg body weight administered intramuscularly for 21 d) were 78 and 23%, respectively.
Subject(s)
Antiprotozoal Agents/therapeutic use , Hyperthermia, Induced/methods , Leishmaniasis, Cutaneous/therapy , Meglumine/therapeutic use , Organometallic Compounds/therapeutic use , Adolescent , Adult , Antiprotozoal Agents/economics , Child , Child, Preschool , Colombia , Female , Humans , Infant , Infant, Newborn , Leishmaniasis, Cutaneous/diagnosis , Leishmaniasis, Cutaneous/economics , Male , Meglumine/economics , Meglumine Antimoniate , Organometallic Compounds/economics , Prospective Studies , Treatment Outcome , Young AdultABSTRACT
American cutaneous leishmaniasis (ACL) has been characterized as a zoonotic disease. However, peridomestic and domestic transmission have been recorded in at least nine countries in Central and South America. The present study was undertaken to identify the etiologic agent of a peridomestic epidemic of ACL in the Department of Tolima, Colombia. Leishmania isolates were obtained during the diagnosis of 56 patients with ACL who consulted the local leishmaniasis control program in three municipalities in Tolima. Species were identified using monoclonal antibodies and isoenzyme electrophoresis. A total of 53 (94.6%) of 56 isolates were identified as Leishmania (Viannia) guyanensis. Three isolates (5.4%) were identified as L. (V.) panamensis. Leishmania (V.) guyanensis is the probable etiologic agent of the largest epidemic of cutaneous leishmaniasis recorded in Colombia. This species has not previously been reported outside the Amazon and southeastern regions of Colombia, and has not been described in the peridomestic setting or linked with an epidemic.
Subject(s)
Leishmania guyanensis/isolation & purification , Leishmaniasis, Cutaneous/epidemiology , Leishmaniasis, Cutaneous/parasitology , Adolescent , Adult , Aged , Animals , Antibodies, Monoclonal/immunology , Antibodies, Protozoan/immunology , Child , Child, Preschool , Colombia/epidemiology , Demography , Female , Humans , Infant , Insect Vectors/parasitology , Insect Vectors/physiology , Isoenzymes/analysis , Leishmania guyanensis/enzymology , Leishmania guyanensis/immunology , Leishmaniasis, Cutaneous/transmission , Male , Middle Aged , Psychodidae/parasitology , Psychodidae/physiology , Species SpecificityABSTRACT
We calculated ranges for the cost per disability adjusted life year (DALY) averted for cutaneous leishmaniasis (CL) treatment during an ongoing epidemic of CL in Chaparral, Colombia. Using operational clinical and cost data, we calculated that the cost of treating leishmaniasis patients with standard pentavalent antimony was US$345 (95% CI 277-488) per patient treated and cured. The cost per DALY averted per patient cured with antimony was estimated to be approximately US$15 000 (95% CI 12 226-21 532).