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

September 9, 2013 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Infectious Disease Department Vall d'Hebron Hospital
      • Barcelona, Spain
        • International Health Unit Drassanes
    • Barcelona
      • Santa Coloma, Barcelona, Spain
        • International Health Unit Metropolitana Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Benznidazole
Drug: Benznidazole
Standard dosage
EXPERIMENTAL: Posaconazole, low dose
Drug: Posaconazole
EXPERIMENTAL: Posaconazole, high dose
Drug: Posaconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after starting treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of treatment, weeks 8, 16, 24 and 40 after treatment
Safety and tolerability of both drugs
Time Frame: First 2 months
First 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (ESTIMATE)

July 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 9, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHAGASAZOL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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