Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|