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

NCT00471705 | Completed Phase 3 Results

• 1 other identifier: PECET-001
• Study Type: interventional
• Target: 437
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cutaneous Leishmaniasis

Keywords

Miltefosine; Leishmaniasis; Glucantime; Thermotherapy; Colombia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Recurrence

  Until 6 months post-treatment

Study Arms (3)

Miltefosine

EXPERIMENTAL

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

Drug: Miltefosine

Glucantime®

ACTIVE COMPARATOR

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

Drug: Glucantime®

Thermotherapy

EXPERIMENTAL

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

Device: Thermotherapy

Interventions

Miltefosine DRUG

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

Also known as: Impavido®

Miltefosine

Thermotherapy DEVICE

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

Also known as: Thermomed

Thermotherapy

Glucantime® DRUG

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

Also known as: Glucantime® (meglumine antimoniate)

Glucantime®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Dirección de Sanidad del Ejército de Colombia (DISAN): collaborator
• Ministerio de Salud y Protección Social, Colombia: collaborator

Study Sites (1)

Program for Research and Control in Tropical Diseases - PECET

Medellín, Antioquia, 1226, Colombia

Location

Related Publications (56)

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• Lopez L, Cruz C, Godoy G, Robledo SM, Velez ID. Thermotherapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia. Rev Inst Med Trop Sao Paulo. 2013;55(3):S0036-46652013000300197. doi: 10.1590/S0036-46652013000300011.

  PMID: 23740007 DERIVED

• Lopez L, Robayo M, Vargas M, Velez ID. Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis. Trials. 2012 May 17;13:58. doi: 10.1186/1745-6215-13-58.

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Related Links

• PECET Web Page

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis; Hyperthermia

Interventions

miltefosine; Hyperthermia, Induced; Meglumine Antimoniate

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Results Point of Contact

• Title: Iván Darío Vélez Bernal
• Organization: Universidad de Antioquia - Colombia

idvelez@pecet-colombia.org

574 + 219 6501 - 02

Study Officials

• Ivan D. Vélez, MD. PhD.

  Program for Research and Control in Tropical Diseases - PECET (Director)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 10, 2007
• Study Start: June 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2009
• Last Updated: January 16, 2019
• Results First Posted: July 14, 2010

Record last verified: 2009-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)