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

NCT ID: NCT01162967

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chagas Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Benznidazole

Group Type ACTIVE_COMPARATOR

Benznidazole

Intervention Type DRUG

Standard dosage

Posaconazole, low dose

Group Type EXPERIMENTAL

Posaconazole

Intervention Type DRUG

Posaconazole, high dose

Group Type EXPERIMENTAL

Posaconazole

Intervention Type DRUG

Interventions

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Benznidazole

Standard dosage

Intervention Type DRUG

Posaconazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Tropical Medicine and International Health Unit Drassanes. Barcelona

UNKNOWN

Sponsor Role collaborator

International Health Unit Metropolitana Nord. Santa Coloma.

UNKNOWN

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Molina Israel, MD

Role: PRINCIPAL_INVESTIGATOR

Infectious Disease Department Vall d'Hebron Hospital

Pahisssa Albert, MD Ph

Role: STUDY_CHAIR

Infectious Disease Department Vall d'Hebron Hospital

Gomez Jordi, MD

Role: PRINCIPAL_INVESTIGATOR

International Health Unit Drassanes

Valerio Lluis, MD

Role: PRINCIPAL_INVESTIGATOR

International Health Unit Metropolitana Nord

Locations

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International Health Unit Metropolitana Nord

Santa Coloma, Barcelona, Spain

Site Status

Infectious Disease Department Vall d'Hebron Hospital

Barcelona, , Spain

Site Status

International Health Unit Drassanes

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 24827034 (View on PubMed)

Other Identifiers

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CHAGASAZOL01

Identifier Type: -

Identifier Source: org_study_id