Cutaneous Leishmaniasis Clinical Trial
Official title:
Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.
NCT number | NCT00471705 |
Other study ID # | PECET-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | December 2009 |
Verified date | June 2009 |
Source | Universidad de Antioquia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown
an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000
new cases of CL were diagnosed in Colombia.
So far, pentavalent antimony compounds have been considered the treatment of choice with a
percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by
their adverse events and disadvantages. Previous studies have shown that miltefosine could be
a potential alternative of treatment for CL.
The main objective of this study is to evaluate the efficacy and safety of miltefosine or
thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of
miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50
celsius degrees during 30 seconds will be compared with the standard treatment of
intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days
in CL parasitologically proven patients.
This trial will be conducted according to the International approved GCP (Good Clinical
Practice) guidelines.
Status | Completed |
Enrollment | 437 |
Est. completion date | December 2009 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Parasitologically proven cases of CL based on positive smear and/or culture. - Patients belonging to the National Colombian Army. - Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician) - Age 18-40 years. - Willing to participate in the study, sign the informed consent , to go to the scheduled visits and to the follow-up visits. - Abstain to receive any other treatment for CL during the trial and follow-up periods. - Non purulent lesions. - Mentally sane volunteers. - No Leishmaniasis treatment in the six months prior to the recruitment. - Number of lesions no more than 5 Exclusion criteria: - None of the lesions must be close to the anal, oral and nasal mucosa, or next to the urogenital and anal canal. - Serious systemic illnesses (as judged by the physician) - Patients with mucosal compromise. - Patients with diffuse Leishmaniasis ( defined as 10 or more cutaneous lesions and negative Montenegro's test) |
Country | Name | City | State |
---|---|---|---|
Colombia | Program for Research and Control in Tropical Diseases - PECET | Medellín | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia | Dirección de Sanidad del Ejército de Colombia (DISAN), Ministerio de Salud y Protección Social, Colombia |
Colombia,
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* Note: There are 54 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Clinical Response | Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment. Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment. |
Until 6 months posttreatment | |
Primary | Failure | At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment | Until 3 months posttreatment | |
Secondary | Recurrence | Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up. | Until 6 months post-treatment |
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