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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier:
NCT01755377
First received: December 19, 2012
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
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 Intervention
Chagas Disease
Drug: Benznidazole

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Barcelona Centre for International Health Research:

Primary Outcome Measures:
  • Biomarkers for prognosis, early diagnosis and effectiveness of treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • 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:
  • Cardiac function after antiparasitic treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    - Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment


Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 63
Study Start Date: December 2012
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755377

Locations
Spain
International Health Department, Hospital Clinic, Barcelona
Barcelona, Cataluña, Spain, 08036
Sponsors and Collaborators
Barcelona Centre for International Health Research
Investigators
Principal Investigator: Joaquim Gascón, PhD Barcelona Centre for International Health Research (CRESIB)
  More Information

Responsible Party: Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier: NCT01755377     History of Changes
Other Study ID Numbers: BIOMARCHA 
Study First Received: December 19, 2012
Last Updated: August 19, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 30, 2016