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

This study is currently recruiting participants.
Verified March 2012 by Hospital Universitari Vall d'Hebron Research Institute
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
ClinicalTrials.gov Identifier:
NCT01162967
First received: May 20, 2010
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Chagas Disease
 Drug: Benznidazole
Drug: Posaconazole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Parasitological cure measured by a real time PCR in blood sample [ Time Frame: 12 months after starting treatment ] [ Designated as safety issue: No ]
    PCR negative at the end of follow up


Secondary Outcome Measures:
  • Parasitological cure measured by real time PCR in blood sample [ Time Frame: End of treatment, weeks 8, 16, 24 and 40 after treatment ] [ Designated as safety issue: No ]
    substained parasitological response

  • Safety and tolerability of both drugs [ Time Frame: First 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Benznidazole Drug: Benznidazole
Standard dosage
Experimental: Posaconazole, low dose Drug: Posaconazole
Experimental: Posaconazole, high dose Drug: Posaconazole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162967

Contacts
Contact: Molina Israel, MD 34932746251 imolina@vhebron.net

Locations
Spain
International Health Unit Metropolitana Nord Recruiting
Santa Coloma, Barcelona, Spain
Contact: Valerio Lluis, MD            
Principal Investigator: Valerio Lluis            
International Health Unit Drassanes Recruiting
Barcelona, Spain
Contact: Gomez Jordi, MD            
Principal Investigator: Gomez Jordi            
Infectious Disease Department Vall d'Hebron Hospital Recruiting
Barcelona, Spain
Contact: Molina Israel, MD            
Principal Investigator: Molina Israel            
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
  More Information

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01162967     History of Changes
Other Study ID Numbers: CHAGASAZOL01
Study First Received: May 20, 2010
Last Updated: March 16, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Posaconazole
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on May 16, 2013