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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487253

Enrollment

150

Registered

2007-06-18

Start date

2007-07-31

Completion date

2010-12-31

Last updated

2010-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous Leishmaniasis, Leishmania Viannia, Pediatric, Miltefosine, Randomized, Colombia

Brief 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.

Interventions

DRUGMeglumine antimoniate

Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

DRUGMiltefosine

Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	26 weeks (6 months)
Evidence of clinical or laboratory toxicity during the treatment period.	During the treatment period (20 or 28 days)

Secondary

Measure	Time frame
Proportion of patients with parasitologic response 26 weeks after the initiation of treatment.	26 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026