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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755377
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Barcelona Centre for International Health Research

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Chagas Disease Drug: Benznidazole

Study Design
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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Serologic Biomarkers and Diastolic Function and Segmentary Contractility Determined by Echocardiography After Treatment in Chagas Diseases
Study Start Date : December 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Migrants from Latin America visiting the Tropical Medicin Clinic
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755377


Locations
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Spain
International Health Department, Hospital Clinic, Barcelona
Barcelona, Cataluña, Spain, 08036
Sponsors and Collaborators
Barcelona Centre for International Health Research
Investigators
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Principal Investigator: Joaquim Gascón, PhD Barcelona Centre for International Health Research (CRESIB)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier: NCT01755377    
Other Study ID Numbers: BIOMARCHA
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents