Trial Condition(s):
Chagas’ disease
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
Bayer Identifier:
20302
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Argentina | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
2
Primary Outcome
- Parasitological cure of adult patients with chronic Chagas’ diseaseChange 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’ diseaseTimeframe: Retrospective analysis from late 1960s to about 1980
Secondary Outcome
- Parasitological cure of pediatric patients with acute and chronic Chagas’ diseaseChange 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’ diseaseTimeframe: Retrospective analysis from late 1960s to about 1980
- Occurrence of cardiac manifestations in patients with chronic Chagas’ diseaseChange 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.Timeframe: Retrospective analysis from late 1960s to about 1980
- Treatment of Cardiomyopathy and/or Heart FailureTimeframe: Retrospective analysis from late 1960s to about 1980
Additional Information
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