Skip to main content
OpenTrials
Completed

NCT Number: NCT03784391

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chagas' Disease Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lampit (Nifurtimox, BAYA2502)

Drug

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

Primary outcomes

  1. Parasitological cure of adult patients with chronic Chagas' disease

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Occurrence of cardiac manifestations in patients with chronic Chagas' disease

    Time frame: 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.

  3. Treatment of Cardiomyopathy and/or Heart Failure

    Time frame: Retrospective analysis from late 1960s to about 1980

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.