Status:
COMPLETED
Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
Lead Sponsor:
Universidad de Antioquia
Collaborating Sponsors:
Dirección de Sanidad del Ejército de Colombia (DISAN)
Ministerio de Salud y Protección Social, Colombia
Conditions:
Cutaneous Leishmaniasis
Eligibility:
MALE
18-40 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Evaluation of Efficacy and Safety of Miltefosine for Cutaneous Leishmaniasis in Colombia Leishmaniasis is taking dramatic dimensions in Colombia, due to its rapid expansion, reemergence (which has mad...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00471705
Start Date
June 1 2006
End Date
December 1 2009
Last Update
January 16 2019
Active Locations (1)
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1
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, Colombia, 1226