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

Completed

• Conditions: Chagas' Disease
• Interventions: Drug: Lampit (Nifurtimox, BAYA2502)

• Registration Number: NCT03784391
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-14
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-21
• Primary Completion: 2020-04-06
• Study Completion: 2020-04-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Lampit (Nifurtimox, BAYA2502)	Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Many locations; 🇦🇷 Multiple Locations, Argentina