Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

Chagas Disease Clinical Trial

Official title:

Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment, Retrospective Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04274101
• Other study ID #: Nifurtimox vs. Benznidazole
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2023
• Source: Hospital de Niños R. Gutierrez de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: February 1, 2025
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Other:
• Clinical Manifestations
Clinical manifestations in patients treated with Nifurtimox and Benznidazole

Diagnostic Test:
• Serologic response
Serologic response in patients treated with Nifurtimox and Benznidazole
• Direct method
Direct method tests in patients treated with Nifurtimox and Benznidazole

Behavioral:
• Adverse events
Adverse events in patients treated with Nifurtimox and Benznidazole

Locations

Country	Name	City	State
Argentina	Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients	To compare Nifurtimox versus Benznidazole treatment efficacy, by measuring serologic response, parasitemia and clinical manifestations in infected patients	Patients treated from 1984 to 2017
Secondary	Nifurtimox versus Benznidazole security and tolerance	To compare Nifurtimox versus Benznidazole security profiles, by measuring adverse events in infected patients and comparing both groups (number of adverse reactions, type and severity of reactions)	Patients treated from 1984 to 2017
Secondary	To compare Chagas disease characteristics associated with treatment	To describe source of infection, age of acquisition of parasite, diagnosis time frame and clinical manifestations that may be associated with treatment response and compare both groups	Patients treated from 1984 to 2017