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

Hospital Universitari Vall d'Hebron Research Institute78 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chagas Disease

Interventions

BenznidazoleDRUG

Standard dosage

PosaconazoleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consenting patients with serological evidence of Chagas infection and positive PCR real time Exclusion Criteria: \-

Locations (3)

International Health Unit Metropolitana Nord

Santa Coloma, Barcelona, Spain

Infectious Disease Department Vall d'Hebron Hospital

Barcelona, Spain

International Health Unit Drassanes

Barcelona, Spain

Outcomes

Primary Outcomes

Parasitological cure measured by a real time PCR in blood sample

PCR negative at the end of follow up

Time frame: 12 months after starting treatment

Secondary Outcomes

Parasitological cure measured by real time PCR in blood sample

substained parasitological response

Time frame: End of treatment, weeks 8, 16, 24 and 40 after treatment

Safety and tolerability of both drugs

Time frame: First 2 months

Data from ClinicalTrials.gov

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