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

Completed

• Conditions: Chagas Disease
• Interventions: Drug: Benznidazole

• Registration Number: NCT01755377
• Lead Sponsor: Barcelona Centre for International Health Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chagas Disease	Benznidazole	Participants diagnosed with Chagas Disease will be followed-up as a Case Group

Primary Outcome Measures

Name	Time	Method
Biomarkers for prognosis, early diagnosis and effectiveness of treatment.	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

Name	Time	Method
Cardiac function after antiparasitic treatment	2 years	- Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment

Trial Locations

Locations (1)

International Health Department, Hospital Clinic, Barcelona; 🇪🇸 Barcelona, Cataluña, Spain