Chagas Disease
Conditions
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.
Interventions
Clinical manifestations in patients treated with Nifurtimox and Benznidazole
DIAGNOSTIC_TESTSerologic response
Serologic response in patients treated with Nifurtimox and Benznidazole
DIAGNOSTIC_TESTDirect method
Direct method tests in patients treated with Nifurtimox and Benznidazole
BEHAVIORALAdverse events
Adverse events in patients treated with Nifurtimox and Benznidazole
Sponsors
Hospital de Niños R. Gutierrez de Buenos Aires
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina
Outcome results
None listed