Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

This study has been completed.
Sponsor:
Information provided by:
Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT00471705
First received: May 7, 2007
Last updated: July 15, 2010
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: Miltefosine
Device: Thermotherapy
Drug: Glucantime®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • Complete Clinical Response [ Time Frame: Until 6 months posttreatment ] [ Designated as safety issue: No ]

    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.


  • Failure [ Time Frame: Until 3 months posttreatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Recurrence [ Time Frame: Until 6 months post-treatment ] [ Designated as safety issue: No ]
    Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.


Enrollment: 437
Study Start Date: June 2006
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Miltefosine
Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
Drug: Miltefosine
Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
Other Name: Impavido®
Active Comparator: Glucantime®
Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
Drug: Glucantime®
Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
Other Name: Glucantime® (meglumine antimoniate)
Experimental: Thermotherapy
One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
Device: Thermotherapy
One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
Other Name: Thermomed

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471705

Locations
Colombia
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, Colombia, 1226
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Principal Investigator: Ivan D. Vélez, MD. PhD. Program for Research and Control in Tropical Diseases - PECET (Director)
  More Information

Publications:
Wilcocks & Manson-Bahr. Manon's tropical diseases.London: Bailliére Tindall; 1972. p. 119-33.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT00471705     History of Changes
Other Study ID Numbers: PECET-001
Study First Received: May 7, 2007
Results First Received: June 14, 2010
Last Updated: July 15, 2010
Health Authority: Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Keywords provided by Universidad de Antioquia:
Miltefosine
Leishmaniasis
Glucantime
Thermotherapy
Colombia

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Miltefosine
Meglumine
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Antifungal Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 14, 2014