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

NCT01755377 | Completed

• 1 other identifier: BIOMARCHA
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Chagas Disease

Outcome Measures

Primary Outcomes (1)

• Biomarkers for prognosis, early diagnosis and effectiveness of treatment.

  * 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 Outcomes (1)

• Cardiac function after antiparasitic treatment

  2 years

Study Arms (2)

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

Interventions

Benznidazole DRUG

Chagas Disease

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Migrants from Latin America visiting the Tropical Medicin Clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barcelona Centre for International Health Research: lead

Study Sites (1)

International Health Department, Hospital Clinic, Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 29351667 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Chagas Disease

Interventions

benzonidazole

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Joaquim Gascón, PhD

  Barcelona Centre for International Health Research (CRESIB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

ES (1)