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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-14

Study Completion Date

2020-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Chagas' Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Treatment

Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox

Lampit (Nifurtimox, BAYA2502)

Intervention Type DRUG

Nifurtimox is a drug already approved in some South American countries since more than 45 years

Reference

Patients diagnosed with acute and chronic Chagas' disease, respectively, who did not receive antitrypanosomal treatment

No interventions assigned to this group

Interventions

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Lampit (Nifurtimox, BAYA2502)

Nifurtimox is a drug already approved in some South American countries since more than 45 years

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No