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

NCT03784391 | Completed

• 1 other identifier: 20302
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chagas' Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Parasitological cure of pediatric patients with acute and chronic Chagas' disease

  Retrospective analysis from late 1960s to about 1980

• Occurrence of cardiac manifestations in patients with chronic Chagas' disease

  Retrospective analysis from late 1960s to about 1980

• Treatment of Cardiomyopathy and/or Heart Failure

  Retrospective analysis from late 1960s to about 1980

Study Arms (2)

Treatment

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

Drug: Lampit (Nifurtimox, BAYA2502)

Reference

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

Interventions

Lampit (Nifurtimox, BAYA2502) DRUG

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

Treatment

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Argentina

Location

Related Publications (1)

• 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.

  PMID: 34606501 DERIVED

Related Links

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

MeSH Terms

Conditions

Chagas Disease

Interventions

Nifurtimox

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Thiazines; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 21, 2018
• Study Start: December 14, 2018
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

AR (1)