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 ]
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