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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00487253
Other study ID # 50100119
Secondary ID
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
Health authority
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

Study Design


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
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