New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease (BIOMARCHA)
This study is currently recruiting participants.
Verified December 2012 by Barcelona Centre for International Health Research
Sponsor:
Barcelona Centre for International Health Research
Information provided by (Responsible Party):
Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier:
NCT01755377
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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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
| Estimated Enrollment: | 63 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2014 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755377
Contacts
| Contact: Edelweiss Aldasoro, MD | +34 932 275 706 ext 2182 | aldasoro@clinic.ub.es |
| Contact: Joaquim Gascón, PhD | +34 932 275 706 ext 3288 | jgascon@clinic.ub.es |
Locations
| Spain | |
| International Health Department, Hospital Clinic, Barcelona | Recruiting |
| Barcelona, Cataluña, Spain, 08036 | |
| Contact: Edelweiss Aldasoro, MD +34 932 275 706 ext 2182 aldasoro@clinic.ub.es | |
| Contact: Joaquim Gascón, PhD +34 932 275 706 ext 3288 jgascon@clinic.ub.es | |
| Sub-Investigator: Edelweiss Aldasoro, MD | |
| Sub-Investigator: Elizabeth Posada | |
| Principal Investigator: Joaquim Gascón, PhD | |
| Sub-Investigator: Ana Garcia, PhD | |
| Sub-Investigator: Ander Regueiro, MD | |
| Sub-Investigator: Mª Carmen Thomas, PhD | |
| Sub-Investigator: Jaime Hernández, MD | |
| Sub-Investigator: Manuel Carlos López, PhD | |
| Sub-Investigator: Miriam Álvarez, PhD | |
Sponsors and Collaborators
Barcelona Centre for International Health Research
Investigators
| Principal Investigator: | Joaquim Gascón, PhD | Barcelona Centre for International Health Research (CRESIB) |
More Information
No publications provided
| 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: | December 19, 2012 |
| 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 Pharmacologic Actions Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013