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Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

H

Hospital de Niños R. Gutierrez de Buenos Aires

Status

Active, not recruiting

Conditions

Chagas Disease

Treatments

Other: Clinical Manifestations
Behavioral: Adverse events
Diagnostic Test: Direct method
Diagnostic Test: Serologic response

Study type

Observational

Funder types

Other

Identifiers

NCT04274101
Nifurtimox vs. Benznidazole

Details and patient eligibility

About

Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission.

Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They both has proven efficacy for acute face treatment, with different security profiles. There are not enough adequate studies comparing both drugs made in a large number of subjects. Investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.

Enrollment

900 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients between 0 and 18 years of age with confirmed Chagas disease (defined as patients under 8 months with positive parasitemia or older with 2 positive different techniques for serology) that received treatment with Nifurtimox or Benznidazole.

Exclusion criteria

  • Patients that abandoned follow-up

Trial design

900 participants in 2 patient groups

Nifurtimox
Description:
Patients treated with Nifurtimox from 1984 to 2017
Treatment:
Behavioral: Adverse events
Diagnostic Test: Direct method
Diagnostic Test: Serologic response
Other: Clinical Manifestations
Benznidazole
Description:
Patients treated with Benznidazole from 1984 to 2017
Treatment:
Behavioral: Adverse events
Diagnostic Test: Direct method
Diagnostic Test: Serologic response
Other: Clinical Manifestations

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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