Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
|ClinicalTrials.gov Identifier: NCT00487253|
Recruitment Status : Unknown
Verified February 2010 by Centro Internacional de Entrenamiento e Investigaciones Médicas.
Recruitment status was: Active, not recruiting
First Posted : June 18, 2007
Last Update Posted : February 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniasis||Drug: Miltefosine Drug: Meglumine antimoniate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||December 2010|
Active Comparator: Group 1
Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days.
presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
Other Name: Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
Active Comparator: Group 2
Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
Drug: Meglumine antimoniate
Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.
Other Name: Glucantime® of Aventis: Amp of 5ml (83mg/ml).
- 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) ]
- Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. [ Time Frame: 26 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487253
|Principal Investigator:||Luisa Consuelo Rubiano, MD, MSc||Centro Internacional de Entrenamiento e Investigaciones Médicas|