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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

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

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

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

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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