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
About this trial
This is an interventional treatment trial for Chagas Disease
Eligibility Criteria
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
NCT ID
NCT01162967
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.
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
Learn more about this trial
Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
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