Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chagas Disease
• Intervention / Treatment: Other: Clinical Manifestations; Diagnostic test: Serologic response; Diagnostic test: Direct method; Behavioral: Adverse events

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients with criteria to receive treatment (Chagas infection confirmed) that received treatment and completed follow-up at Parasitology and Chagas department of Children's Hospital Ricardo Gutierrez, Argentina.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nifurtimox; Patients treated with Nifurtimox from 1984 to 2017	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; Diagnostic test: Direct method; Direct method tests in patients treated with Nifurtimox and Benznidazole; Behavioral: Adverse events; Adverse events in patients treated with Nifurtimox and Benznidazole
Benznidazole; Patients treated with Benznidazole from 1984 to 2017	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; Diagnostic test: Direct method; Direct method tests in patients treated with Nifurtimox and Benznidazole; Behavioral: Adverse events; Adverse events in patients treated with Nifurtimox and Benznidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Publications and helpful links

General Publications

• Falk N, Berenstein AJ, Moscatelli G, Moroni S, Gonzalez N, Ballering G, Freilij H, Altcheh J. Effectiveness of Nifurtimox in the Treatment of Chagas Disease: a Long-Term Retrospective Cohort Study in Children and Adults. Antimicrob Agents Chemother. 2022 May 17;66(5):e0202121. doi: 10.1128/aac.02021-21. Epub 2022 Apr 13.
• Berenstein AJ, Falk N, Moscatelli G, Moroni S, Gonzalez N, Garcia-Bournissen F, Ballering G, Freilij H, Altcheh J. Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults. Antimicrob Agents Chemother. 2021 Jan 20;65(2):e01135-20. doi: 10.1128/AAC.01135-20. Print 2021 Jan 20.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): August 1, 2020
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Chagas Disease
• Other Study ID Numbers: Nifurtimox vs. Benznidazole

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No