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Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole (CHAGASAZOL)

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ClinicalTrials.gov Identifier: NCT01162967
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : September 10, 2013
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Tropical Medicine and International Health Unit Drassanes. Barcelona
International Health Unit Metropolitana Nord. Santa Coloma.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.

Condition or disease Intervention/treatment Phase
Chagas Disease Drug: Benznidazole Drug: Posaconazole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE
Study Start Date : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Benznidazole Drug: Benznidazole
Standard dosage
Experimental: Posaconazole, low dose Drug: Posaconazole
Experimental: Posaconazole, high dose Drug: Posaconazole



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Safety and tolerability of both drugs [ Time Frame: First 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consenting patients with serological evidence of Chagas infection and positive PCR real time

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162967


Locations
Spain
International Health Unit Metropolitana Nord
Santa Coloma, Barcelona, Spain
Infectious Disease Department Vall d'Hebron Hospital
Barcelona, Spain
International Health Unit Drassanes
Barcelona, Spain
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Hospital Vall d'Hebron
Tropical Medicine and International Health Unit Drassanes. Barcelona
International Health Unit Metropolitana Nord. Santa Coloma.
Investigators
Principal Investigator: Molina Israel, MD Infectious Disease Department Vall d'Hebron Hospital
Study Chair: Pahisssa Albert, MD Ph Infectious Disease Department Vall d'Hebron Hospital
Principal Investigator: Gomez Jordi, MD International Health Unit Drassanes
Principal Investigator: Valerio Lluis, MD International Health Unit Metropolitana Nord

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01162967     History of Changes
Other Study ID Numbers: CHAGASAZOL01
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Posaconazole
Benzonidazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors