Clinical Trial: The Association of Miltefosine and Pentoxifylline to Treat Mucosal Leishmaniasis: A Clinical Trial in Brazil

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Association of Miltefosine and Pentoxifylline to Treat Mucosal Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil

Brief Summary: Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.

Detailed Summary:
Sponsor: University of Brasilia

Current Primary Outcome:

• Cure [ Time Frame: 90 days ]
  Complete healing of previous lesions until the 90th day after the begin of the treatment
• Failure [ Time Frame: 90 days ]
  Lesions fail to heal until the 90th after treatment begin of the treatment
• Relapse [ Time Frame: 90 days ]
  Lesions that reappear on the scar of a previously healed lesion

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Brasilia

Dates:
Date Received: August 19, 2015
Date Started: August 2015
Date Completion: June 2018
Last Updated: May 22, 2016
Last Verified: May 2016