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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifurtimox | Patients treated with Nifurtimox from 1984 to 2017 |
| |
| Benznidazole | Patients treated with Benznidazole from 1984 to 2017 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Manifestations | Other | Clinical manifestations in patients treated with Nifurtimox and Benznidazole |
|
| 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 |
| 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 |
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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
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parasitology and Chagas Service, Buenos Aires Children“s Hospital Ricardo Gutierrez | Buenos Aires | 1425 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35416710 | Derived | 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. | |
| 33168612 |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| Serologic response | Diagnostic Test | Serologic response in patients treated with Nifurtimox and Benznidazole |
|
| Direct method | Diagnostic Test | Direct method tests in patients treated with Nifurtimox and Benznidazole |
|
| Adverse events | Behavioral | Adverse events in patients treated with Nifurtimox and Benznidazole |
|
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 |
| 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. |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |