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

August 19, 2016 updated by: Barcelona Centre for International Health Research

Evolution of Serologic Biomarkers and Diastolic Function and Segmentary Contractility Determined by Echocardiography After Treatment in Chagas Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • International Health Department, Hospital Clinic, Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Migrants from Latin America visiting the Tropical Medicin Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Chagas Disease
Participants with no Chagas Disease will be evaluated as a Control Group
Chagas Disease
Participants diagnosed with Chagas Disease will be followed-up as a Case Group
Drug: Benznidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers for prognosis, early diagnosis and effectiveness of treatment.
Time Frame: 2 years
  • Conventional polymerase chain reaction of T. cruzi in blood
  • Measurement of Brain natriuretic factor
  • Measurement of Prothrombotic factors
  • Measurement of antibodies against specific proteins of the trypomastigote of T. cruzi
  • Investigation of the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function after antiparasitic treatment
Time Frame: 2 years
- Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barcelona Centre for International Health Research

Investigators

  • Principal Investigator: Joaquim Gascón, PhD, Barcelona Centre for International Health Research (CRESIB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOMARCHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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