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

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

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.

Study Overview

• Status: Completed
• Conditions: Chagas' Disease
• Intervention / Treatment: Drug: Lampit (Nifurtimox, BAYA2502)

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Argentina
  • Multiple Locations, Argentina
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will comprise adult and pediatric patients diagnosed with Chagas' disease, respectively, who were treated with nifurtimox (nifurtimox groups). An untreated reference group comprising adult patients diagnosed with chronic Chagas' disease, who did not receive antitrypanosomal treatment will be considered.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox	Drug: Lampit (Nifurtimox, BAYA2502); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Treatment of Cardiomyopathy and/or Heart Failure		Retrospective analysis from late 1960s to about 1980

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Vizcaya D, Grossmann U, Kleinjung F, Zhang R, Suzart-Woischnik K, Seu S, Ramirez T, Colmegna L, Ledesma O. Serological response to nifurtimox in adult patients with chronic Chagas disease: An observational comparative study in Argentina. PLoS Negl Trop Dis. 2021 Oct 4;15(10):e0009801. doi: 10.1371/journal.pntd.0009801. eCollection 2021 Oct.

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): April 6, 2020
• Study Completion (Actual): April 6, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Chagas Disease; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Trypanocidal Agents; Nifurtimox
• Other Study ID Numbers: 20302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No