Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas' Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Parasitological cure of adult patients with chronic Chagas' disease
timeFrame: Retrospective analysis from late 1960s to about 1980
Secondary outcomes:
measure: Parasitological cure of pediatric patients with acute and chronic Chagas' disease
timeFrame: Retrospective analysis from late 1960s to about 1980
measure: Occurrence of cardiac manifestations in patients with chronic Chagas' disease
timeFrame: Retrospective analysis from late 1960s to about 1980
measure: Treatment of Cardiomyopathy and/or Heart Failure
timeFrame: Retrospective analysis from late 1960s to about 1980
Other outcomes:
Locations:
city: Multiple Locations
country: Argentina
facility: Many locations
Study officials:
References:
citation: 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.