Chagas' Disease
Conditions
Brief summary
The researchers in this trial want to analyze prerecorded patient data which provide information on benefits of the drug nifurtimox in patients with a sudden (acute) and long lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans by a bug. They also want to learn how often organs, especially the heart, are affected by the illness in treated and untreated chronic Chaga's patients. In order to find this out medical records of adult and pediatric patients in Argentina will be analyzed.
Interventions
DRUGLampit (Nifurtimox, BAYA2502)
Nifurtimox is a drug already approved in some South American countries since more than 45 years
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged ≥0 years at time of diagnosis with Chagas' disease * Diagnosis of Chagas' disease confirmed by parasitological and/or serological method(s) before start of antitrypanosomal treatment or during the course of this antitrypanosomal treatment cycle for the first episode recorded.
Exclusion criteria
* Treatment with antitrypanosomal agent(s) other than nifurtimox, including experimental investigational products for Chagas' disease or antitrypanosomal combination treatment * Patients with known evidence of organ manifestation of chronic Chagas' disease, e.g.Chagas' disease-related cardiomyopathy/heart disease, Chagas' disease-related digestive disease at time of primary diagnosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parasitological cure of adult patients with chronic Chagas' disease | Retrospective analysis from late 1960s to about 1980 | Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline. Adults are defined as patients who were 18 years or older at the time of initial diagnosis of acute or chronic Chagas' disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parasitological cure of pediatric patients with acute and chronic Chagas' disease | Retrospective analysis from late 1960s to about 1980 | Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline. Pediatric population will comprise patients aged 0 to below 18 years at the time of initial diagnosis of acute or chronic Chagas' disease |
| Occurrence of cardiac manifestations in patients with chronic Chagas' disease | Retrospective analysis from late 1960s to about 1980 | Change from a lower to a more advanced Kuschnir group or cardiac death (change of clinical group) and appearance of new abnormalities on ECG compared to baseline. |
| Treatment of Cardiomyopathy and/or Heart Failure | Retrospective analysis from late 1960s to about 1980 | — |
Countries
Argentina
Outcome results
None listed