Trial Condition(s):

Chagas’ disease

Study on benefits of therapy with nifurtimox in Chagas disease, a parasitic illness mostly transmitted to humans by a bug, using information from patient medical records in Argentina

Bayer Identifier:

20302

ClinicalTrials.gov Identifier:

NCT03784391

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
3000
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Lampit (Nifurtimox, BAYA2502)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Argentina

Status
Not yet recruiting
 

Trial Design