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| Sponsors and Collaborators: |
Centro Internacional de Entrenamiento e Investigaciones Médicas Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) INS Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta |
| Information provided by: | Centro Internacional de Entrenamiento e Investigaciones Médicas |
| ClinicalTrials.gov Identifier: | NCT00487253 |
Purpose
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.
| Condition | Intervention | Phase |
|
Cutaneous Leishmaniasis |
Drug: miltefosine Drug: meglumine antimoniate |
Phase III |
| MedlinePlus related topics: | Leishmaniasis |
| ChemIDplus related topics: | Miltefosine Glucantime Meglumine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia |
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2007 |
Eligibility
| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maria Consuelo Miranda, MD, MSc | (571)6682164 ext 216 | clinico@cideim.org.co |
| Contact: Isabel Rodriguez, MD | (571)6682164 ext 307 | irodriguez@cideim.org.co |
| Colombia, Valle del Cauca | |||||
| CIDEIM | Recruiting | ||||
| Cali, Valle del Cauca, Colombia | |||||
| Contact: Maria Consuelo Miranda, MD, MSc (571) 6682164 clinico@cideim.org.co | |||||
| Centro Internacional de Entrenamiento e Investigaciones Médicas |
| Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) |
| INS |
| Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta |
| Principal Investigator: | Maria Consuelo Miranda, MD, MSc | Centro Internacional de Entrenamiento e Investigaciones Médicas |
More Information
| Study ID Numbers: | 50100119 |
| First Received: | June 14, 2007 |
| Last Updated: | July 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00487253 |
| Health Authority: | Colombia: Institutional Review Board |
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