| June 14, 2007 |
| July 26, 2007 |
| July 2007 |
| |
- The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria. [ Time Frame: 26 weeks (6 months) ]
- Evidence of clinical or laboratory toxicity during the treatment period. [ Time Frame: During the treatment period (20 or 28 days) ]
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- The primary outcome measure will be the proportion of “Therapeutic Failures” diagnosed during the final (week 26) visit or before, according to defined clinical criteria. [ Time Frame: 26 weeks (6 months) ]
- Evidence of clinical or laboratory toxicity during the treatment period. [ Time Frame: During the treatment period (20 or 28 days) ]
|
| Complete list of historical versions of study NCT00487253 on ClinicalTrials.gov Archive Site |
| Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. [ Time Frame: 26 weeks ] |
| Same as current |
| |
| Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia |
| Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Cutaneous Leishmaniasis |
- Drug: miltefosine
- Drug: meglumine antimoniate
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| |
| |
| |
| Recruiting |
| 150 |
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Inclusion Criteria:
- 2 to 12 years of age (inclusive)
- Parasitologically confirmed CL
- Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed")
- Availability to return for follow-up visits for at least 6 months after treatment is initiated
Exclusion Criteria:
- Weight under 10kg
- Previous use of SbV, miltefosine or other antileishmanial therapy
- Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis
- If a girl, ability to reproduce (history of menarche)
- Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease
- Patients with pretreatment haemoglobin <10g/dl or blood urea nitrogen (BUN), serum creatinine, ALT, AST or amylase values that exceed the upper limit of normal
- If living in Malaria endemic areas (eg. Tumaco) only: A positive malaria thick smear
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| Both |
| 2 Years to 12 Years |
| No |
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| Colombia |
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| NCT00487253 |
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| 50100119 |
| 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
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| Principal Investigator: |
Maria Consuelo Miranda, MD, MSc |
Centro Internacional de Entrenamiento e Investigaciones Médicas |
|
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| Centro Internacional de Entrenamiento e Investigaciones Médicas |
| July 2007 |
