Clinical Trial: Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE

Brief Summary: The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.

Detailed Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: Parasitological cure measured by a real time PCR in blood sample [ Time Frame: 12 months after starting treatment ]

PCR negative at the end of follow up


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Parasitological cure measured by real time PCR in blood sample [ Time Frame: End of treatment, weeks 8, 16, 24 and 40 after treatment ]
    substained parasitological response
  • Safety and tolerability of both drugs [ Time Frame: First 2 months ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: May 20, 2010
Date Started: September 2010
Date Completion:
Last Updated: September 9, 2013
Last Verified: September 2013