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

Primary Purpose

Chagas Disease

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Benznidazole
Posaconazole
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • International Health Unit Metropolitana Nord
  • Infectious Disease Department Vall d'Hebron Hospital
  • International Health Unit Drassanes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Benznidazole

Posaconazole, low dose

Posaconazole, high dose

Arm Description

Outcomes

Primary Outcome Measures

Parasitological cure measured by a real time PCR in blood sample
PCR negative at the end of follow up

Secondary Outcome Measures

Parasitological cure measured by real time PCR in blood sample
substained parasitological response
Safety and tolerability of both drugs

Full Information

First Posted
May 20, 2010
Last Updated
September 9, 2013
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.
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1. Study Identification

Unique Protocol Identification Number
NCT01162967
Brief Title
Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
Acronym
CHAGASAZOL
Official Title
PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benznidazole
Arm Type
Active Comparator
Arm Title
Posaconazole, low dose
Arm Type
Experimental
Arm Title
Posaconazole, high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Benznidazole
Intervention Description
Standard dosage
Intervention Type
Drug
Intervention Name(s)
Posaconazole
Primary Outcome Measure Information:
Title
Parasitological cure measured by a real time PCR in blood sample
Description
PCR negative at the end of follow up
Time Frame
12 months after starting treatment
Secondary Outcome Measure Information:
Title
Parasitological cure measured by real time PCR in blood sample
Description
substained parasitological response
Time Frame
End of treatment, weeks 8, 16, 24 and 40 after treatment
Title
Safety and tolerability of both drugs
Time Frame
First 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consenting patients with serological evidence of Chagas infection and positive PCR real time Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molina Israel, MD
Organizational Affiliation
Infectious Disease Department Vall d'Hebron Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pahisssa Albert, MD Ph
Organizational Affiliation
Infectious Disease Department Vall d'Hebron Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gomez Jordi, MD
Organizational Affiliation
International Health Unit Drassanes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valerio Lluis, MD
Organizational Affiliation
International Health Unit Metropolitana Nord
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Health Unit Metropolitana Nord
City
Santa Coloma
State/Province
Barcelona
Country
Spain
Facility Name
Infectious Disease Department Vall d'Hebron Hospital
City
Barcelona
Country
Spain
Facility Name
International Health Unit Drassanes
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24827034
Citation
Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122.
Results Reference
derived

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

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