Trials / Unknown
UnknownNCT00487253
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Centro Internacional de Entrenamiento e Investigaciones Médicas · Academic / Other
- Sex
- All
- Age
- 2 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Miltefosine | Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days. |
| DRUG | Meglumine antimoniate | Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2010-02-01
- Completion
- 2010-12-01
- First posted
- 2007-06-18
- Last updated
- 2010-02-17
Source: ClinicalTrials.gov record NCT00487253. Inclusion in this directory is not an endorsement.