Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Chagas Disease

Intervention / Treatment
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* Other: Clinical Manifestations
* Diagnostic Test: Serologic response
* Diagnostic Test: Direct method
* Behavioral: Adverse events


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nifurtimox<br>Patients treated with Nifurtimox from 1984 to 2017 | Other: Clinical Manifestations<br>* Clinical manifestations in patients treated with Nifurtimox and Benznidazole<br>Diagnostic Test: Serologic response<br>* Serologic response in patients treated with Nifurtimox and Benznidazole<br>Diagnostic Test: Direct method<br>* Direct method tests in patients treated with Nifurtimox and Benznidazole<br>Behavioral: Adverse events<br>* Adverse events in patients treated with Nifurtimox and Benznidazole<br>|
| Benznidazole<br>Patients treated with Benznidazole from 1984 to 2017 | Other: Clinical Manifestations<br>* Clinical manifestations in patients treated with Nifurtimox and Benznidazole<br>Diagnostic Test: Serologic response<br>* Serologic response in patients treated with Nifurtimox and Benznidazole<br>Diagnostic Test: Direct method<br>* Direct method tests in patients treated with Nifurtimox and Benznidazole<br>Behavioral: Adverse events<br>* Adverse events in patients treated with Nifurtimox and Benznidazole<br>|

What is the study measuring?
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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 |