drugset / Trial / NCT00487253
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Phase 3
Unknown
150 enrolled
International Center for Training and Medical Research
INS · collabInstituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) · collabInstituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.
Timeline
- Start
- 2007-07
- Primary completion
- 2010-02
- Completion
- 2010-12
Publications
- Castro MDM, Cossio A, Velasco C, Osorio L. Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Negl Trop Dis. 2017 Apr 5;11(4):e0005515. doi: 10.1371/journal.pntd.0005515. eCollection 2017 Apr.
- Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodriguez-Barraquer I, Garcerant D, Prager M, Osorio L, Rojas MX, Perez M, Nicholls RS, Gore Saravia N. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. J Infect Dis. 2012 Feb 15;205(4):684-92. doi: 10.1093/infdis/jir816. Epub 2012 Jan 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Meglumine antimonate | Other / unclassified | 20 mg/kg | Intramuscular |
| Comparator | Miltefosine | Small molecule | 1.5 mg/kg | Oral |
| Comparator | Miltefosine | Small molecule | 2.5 mg/kg | Oral |