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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

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Bayer

Status

Completed

Conditions

Chagas' Disease

Treatments

Drug: Lampit (Nifurtimox, BAYA2502)

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

3,000 patients

Sex

All

Volunteers

No Healthy Volunteers

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 design

3,000 participants in 2 patient groups

Treatment
Description:
Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox
Treatment:
Drug: Lampit (Nifurtimox, BAYA2502)
Reference
Description:
Patients diagnosed with acute and chronic Chagas' disease, respectively, who did not receive antitrypanosomal treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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