New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

NCT ID: NCT01755377

Last Updated: 2016-08-22

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

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-06-30

Brief Summary

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Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.

Detailed Description

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Conditions

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Chagas Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No Chagas Disease

Participants with no Chagas Disease will be evaluated as a Control Group

No interventions assigned to this group

Chagas Disease

Participants diagnosed with Chagas Disease will be followed-up as a Case Group

Benznidazole

Intervention Type DRUG

Interventions

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Benznidazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients from endemic areas (Latin America)
* Older than 18 years old and younger than 50
* With serological confirmation of Chagas Disease infection with two different techniques
* Indeterminate or initial cardiac form
* No previously treated for Chagas Disease

Exclusion Criteria

* Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barcelona Centre for International Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joaquim Gascón, PhD

Role: PRINCIPAL_INVESTIGATOR

Barcelona Centre for International Health Research (CRESIB)

Locations

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International Health Department, Hospital Clinic, Barcelona

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

References

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Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.

Reference Type DERIVED
PMID: 29351667 (View on PubMed)

Other Identifiers

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BIOMARCHA

Identifier Type: -

Identifier Source: org_study_id

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