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

Chagas' Disease Clinical Trial

Official title:

Effectiveness of Nifurtimox in Patients With Chagas' Disease Based on Data From Patient Medical Records in Argentina: a Retrospective Medical Chart Review Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784391
• Other study ID #: 20302
• Status: Completed
• Start date: December 14, 2018
• Est. completion date: April 6, 2020

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chagas Disease
• Chagas' Disease

Intervention

Drug:
• Lampit (Nifurtimox, BAYA2502)
Nifurtimox is a drug already approved in some South American countries since more than 45 years

Locations

Country	Name	City	State
Argentina	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasitological cure of adult patients with chronic Chagas' disease	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	Retrospective analysis from late 1960s to about 1980
Secondary	Parasitological cure of pediatric patients with acute and chronic Chagas' disease	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	Retrospective analysis from late 1960s to about 1980
Secondary	Occurrence of cardiac manifestations in patients with chronic Chagas' disease	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.	Retrospective analysis from late 1960s to about 1980
Secondary	Treatment of Cardiomyopathy and/or Heart Failure		Retrospective analysis from late 1960s to about 1980

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