Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is:

1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of chronic Chagas disease in adult patients by means of a randomized, double-blind clinical trial (RCT).

Also:

2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared with conventional serology (CS)

3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite load as an early therapeutic effect.

4. to determine the potential of such serological and parasitological methods as predictors of therapeutic effect or failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
• Collaborators: Becas Carrillo Oñativia, Ministerio de Salud, Argentina; Drugs for Neglected Diseases; National Council of Scientific and Technical Research, Argentina; Pan American Health Organization
• Treatments: Benzonidazole

Criteria

Inclusion Criteria:

• Patients living in urban areas

• Reactive to at least 2 for serological test performed in Fatala Chaben Institute (ELISA and IFI) ,

• Patients who agreed to be part of this protocol through informed consent form signed

Exclusion Criteria:

• Patients with chronic Chagas disease who have received prior treatment with benznidazole

• Other cardiomyopathies : idiopathic , alcoholic , peripartum myocarditis, secondary to coronary artery disease, valve disease, hypertension, restrictive, hypertrophic or congenital

• Chronic renal disease

• Bleeding disorders

• History of liver disease or current liver disease ,

• Any other severe clinical disease that decreases their life expectancy

• History of severe allergies

• Pregnant patients

• Patients who have not signed the informed consent.