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

Phase 2

Completed

• Conditions: Chagas Disease
• Interventions: Drug: Posaconazole; Drug: Benznidazole

• Registration Number: NCT01162967
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2010-09
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posaconazole, low dose	Posaconazole	-
Benznidazole	Benznidazole	-
Posaconazole, high dose	Posaconazole	-

Primary Outcome Measures

Name	Time	Method
Parasitological cure measured by a real time PCR in blood sample	12 months after starting treatment	PCR negative at the end of follow up

Secondary Outcome Measures

Name	Time	Method
Parasitological cure measured by real time PCR in blood sample	End of treatment, weeks 8, 16, 24 and 40 after treatment	substained parasitological response
Safety and tolerability of both drugs	First 2 months

Trial Locations

Locations (3)

International Health Unit Drassanes; 🇪🇸 Barcelona, Spain

Infectious Disease Department Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain

International Health Unit Metropolitana Nord; 🇪🇸 Santa Coloma, Barcelona, Spain