check_circleStudy Completed

Chagas’ disease

Bayer Identifier:

20302

ClinicalTrials.gov Identifier:

NCT03784391

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

0 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
3000
Trial Dates
December 2018 - April 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Lampit (Nifurtimox, BAYA2502)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Many locationsMany locations, Argentina

Primary Outcome

  • 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
    date_rangeTime Frame:
    Retrospective analysis from late 1960s to about 1980

Secondary Outcome

  • 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
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective analysis from late 1960s to about 1980
  • Treatment of Cardiomyopathy and/or Heart Failure
    date_rangeTime Frame:
    Retrospective analysis from late 1960s to about 1980

Trial design

Effectiveness of nifurtimox in patients with Chagas’ disease based on data from patient medical records in Argentina: a retrospective medical chart review study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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