Chagas' DiseaseNCT03784391
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
An observational study of Chagas' Disease, run by Bayer at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Chagas' Disease
- What is being tested?
- Lampit (Nifurtimox, BAYA2502)
- How many people
- 3,000 participants
- Where
- 1 siteArgentina
- Study dates
- 14 Dec 2018to 6 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Lampit (Nifurtimox, BAYA2502)
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lampit (Nifurtimox, BAYA2502)Drug
Nifurtimox is a drug already approved in some South American countries since more than 45 years
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox Receives: Drug: Lampit (Nifurtimox, BAYA2502) | |
| Reference | Patients diagnosed with acute and chronic Chagas' disease, respectively, who did not receive antitrypanosomal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Retrospective analysis from late 1960s to about 1980
Secondary outcomes (3)
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
Measured: 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.
Measured: Retrospective analysis from late 1960s to about 1980
Treatment of Cardiomyopathy and/or Heart Failure
Measured: Retrospective analysis from late 1960s to about 1980
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start14 Dec 2018
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas' DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784391
- Sponsor's protocol ID
- 20302
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34606501
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03784391
- Acronym / sponsor ID
- 20302
- Conditions
- Chagas' Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Lampit (Nifurtimox, BAYA2502)Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox |
| Reference | – | –Patients diagnosed with acute and chronic Chagas' disease, respectively, who did not receive antitrypanosomal treatment |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lampit (Nifurtimox, BAYA2502)Nifurtimox is a drug already approved in some South American countries since more than 45 years | Drug | Treatment |
Primary outcome
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
3 secondary outcomes
Parasitological cure of pediatric patients with acute and chronic Chagas' disease
Time frame: Retrospective analysis from late 1960s to about 1980
Occurrence of cardiac manifestations in patients with chronic Chagas' disease
Time frame: Retrospective analysis from late 1960s to about 1980
Treatment of Cardiomyopathy and/or Heart Failure
Time frame: Retrospective analysis from late 1960s to about 1980
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 34606501Vizcaya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas' Disease, run by Bayer at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasitological cure of adult patients with chronic Chagas' disease (time frame: Retrospective analysis from late 1960s to about 1980). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.