Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

Cutaneous Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00487253
• Other study ID #: 50100119
• Status: Unknown status
• Phase: Phase 3
• First received: June 14, 2007
• Last updated: February 13, 2010
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Centro Internacional de Entrenamiento e Investigaciones Médicas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Miltefosine
Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
• Meglumine antimoniate
Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Centro Internacional de Entrenamiento e Investigaciones Médicas	INS, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Evidence of clinical or laboratory toxicity during the treatment period.		During the treatment period (20 or 28 days)
Secondary	Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.		26 weeks