Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

Active, not recruiting

• Conditions: Chagas Disease
• Interventions: Other: Clinical Manifestations; Diagnostic Test: Serologic response; Diagnostic Test: Direct method; Behavioral: Adverse events

• Registration Number: NCT04274101
• Lead Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Primary Completion: 2020-08-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nifurtimox	Clinical Manifestations	Patients treated with Nifurtimox from 1984 to 2017
Nifurtimox	Adverse events	Patients treated with Nifurtimox from 1984 to 2017
Benznidazole	Adverse events	Patients treated with Benznidazole from 1984 to 2017
Nifurtimox	Direct method	Patients treated with Nifurtimox from 1984 to 2017
Benznidazole	Clinical Manifestations	Patients treated with Benznidazole from 1984 to 2017
Nifurtimox	Serologic response	Patients treated with Nifurtimox from 1984 to 2017
Benznidazole	Serologic response	Patients treated with Benznidazole from 1984 to 2017
Benznidazole	Direct method	Patients treated with Benznidazole from 1984 to 2017

Primary Outcome Measures

Name	Time	Method
Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients	Patients treated from 1984 to 2017	To compare Nifurtimox versus Benznidazole treatment efficacy, by measuring serologic response, parasitemia and clinical manifestations in infected patients

Secondary Outcome Measures

Name	Time	Method
Nifurtimox versus Benznidazole security and tolerance	Patients treated from 1984 to 2017	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)
To compare Chagas disease characteristics associated with treatment	Patients treated from 1984 to 2017	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

Trial Locations

Locations (1)

Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez; 🇦🇷 Buenos Aires, Argentina