Chagas DiseaseNCT04274101
Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment
An observational study of Chagas Disease, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
Trial summary
Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission. Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Clinical Manifestations, Serologic response and Direct method
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2018to 1 Feb 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric patients with criteria to receive treatment (Chagas infection confirmed) that received treatment and completed follow-up at Parasitology and Chagas department of Children's Hospital Ricardo Gutierrez, Argentina.
Who may be able to join
- Patients between 0 and 18 years of age with confirmed Chagas disease (defined as patients under 8 months with positive parasitemia or older with 2 positive different techniques for serology) that received treatment with Nifurtimox or Benznidazole.
Who cannot join
- Patients that abandoned follow-up
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, 1425
About this study
Official title: Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment, Retrospective Cohort
Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission.
Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They both has proven efficacy for acute face treatment, with different security profiles. There are not enough adequate studies comparing both drugs made in a large number of subjects. Investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.
- Conditions
- Chagas Disease
- Being tested
- Clinical Manifestations, Serologic response, Direct method, Adverse events
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ManifestationsOther
Clinical manifestations in patients treated with Nifurtimox and Benznidazole
Serologic responseDiagnostic test
Serologic response in patients treated with Nifurtimox and Benznidazole
Direct methodDiagnostic test
Direct method tests in patients treated with Nifurtimox and Benznidazole
Adverse eventsBehavioural
Adverse events in patients treated with Nifurtimox and Benznidazole
| Study group | Role | What they receive |
|---|---|---|
| Nifurtimox | Patients treated with Nifurtimox from 1984 to 2017 Receives: Other: Clinical Manifestations; Diagnostic Test: Serologic response; Diagnostic Test: Direct method; Behavioral: Adverse events | |
| Benznidazole | Patients treated with Benznidazole from 1984 to 2017 Receives: Other: Clinical Manifestations; Diagnostic Test: Serologic response; Diagnostic Test: Direct method; Behavioral: Adverse events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients
To compare Nifurtimox versus Benznidazole treatment efficacy, by measuring serologic response, parasitemia and clinical manifestations in infected patients
Measured: Patients treated from 1984 to 2017
Secondary outcomes (2)
Nifurtimox versus Benznidazole security and tolerance
To compare Nifurtimox versus Benznidazole security profiles, by measuring adverse events in infected patients and comparing both groups (number of adverse reactions, type and severity of reactions)
Measured: Patients treated from 1984 to 2017
To compare Chagas disease characteristics associated with treatment
To describe source of infection, age of acquisition of parasite, diagnosis time frame and clinical manifestations that may be associated with treatment response and compare both groups
Measured: Patients treated from 1984 to 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Jun 2018
- Primary completion1 Aug 2020
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274101
- Sponsor's protocol ID
- Nifurtimox vs. Benznidazole
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falk N, Berenstein AJ, Moscatelli G, Moroni S, Gonzalez N, Ballering G, Freilij H, Altcheh J. Effectiveness of Nifurtimox in the Treatment of Chagas Disease: a Long-Term Retrospective Cohort Study in Children and Adults. Antimicrob Agents Chemother. 2022 May 17;66(5):e0202121. doi: 10.1128/aac.02021-21. Epub 2022 Apr 13.
PubMed 35416710Berenstein AJ, Falk N, Moscatelli G, Moroni S, Gonzalez N, Garcia-Bournissen F, Ballering G, Freilij H, Altcheh J. Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults. Antimicrob Agents Chemother. 2021 Jan 20;65(2):e01135-20. doi: 10.1128/AAC.01135-20. Print 2021 Jan 20.
PubMed 33168612
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment, Retrospective Cohort
- ClinicalTrials.gov ID
- NCT04274101
- Acronym / sponsor ID
- Nifurtimox vs. Benznidazole
- Conditions
- Chagas Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 18 Feb 2020 (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.
Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission.
Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They both has proven efficacy for acute face treatment, with different security profiles. There are not enough adequate studies comparing both drugs made in a large number of subjects. Investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifurtimox | – | Other: Clinical Manifestations, Diagnostic Test: Serologic response, Diagnostic Test: Direct method, Behavioral: Adverse eventsPatients treated with Nifurtimox from 1984 to 2017 |
| Benznidazole | – | Other: Clinical Manifestations, Diagnostic Test: Serologic response, Diagnostic Test: Direct method, Behavioral: Adverse eventsPatients treated with Benznidazole from 1984 to 2017 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients with criteria to receive treatment (Chagas infection confirmed) that received treatment and completed follow-up at Parasitology and Chagas department of Children's Hospital Ricardo Gutierrez, Argentina.
Key inclusion criteria (1 listed)
- Patients between 0 and 18 years of age with confirmed Chagas disease (defined as patients under 8 months with positive parasitemia or older with 2 positive different techniques for serology) that received treatment with Nifurtimox or Benznidazole.
Key exclusion criteria (1 listed)
- Patients that abandoned follow-up
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 |
|---|---|---|
| Clinical ManifestationsClinical manifestations in patients treated with Nifurtimox and Benznidazole | Other | Benznidazole, Nifurtimox |
| Serologic responseSerologic response in patients treated with Nifurtimox and Benznidazole | Diagnostic test | Benznidazole, Nifurtimox |
| Direct methodDirect method tests in patients treated with Nifurtimox and Benznidazole | Diagnostic test | Benznidazole, Nifurtimox |
| Adverse eventsAdverse events in patients treated with Nifurtimox and Benznidazole | Behavioural | Benznidazole, Nifurtimox |
Primary outcome
Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients
Time frame: Patients treated from 1984 to 2017
To compare Nifurtimox versus Benznidazole treatment efficacy, by measuring serologic response, parasitemia and clinical manifestations in infected patients
2 secondary outcomes
Nifurtimox versus Benznidazole security and tolerance
Time frame: Patients treated from 1984 to 2017
To compare Chagas disease characteristics associated with treatment
Time frame: Patients treated from 1984 to 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 35416710Falk N, Berenstein AJ, Moscatelli G, Moroni S, Gonzalez N, Ballering G, Freilij H, Altcheh J. Effectiveness of Nifurtimox in the Treatment of Chagas Disease: a Long-Term Retrospective Cohort Study in Children and Adults. Antimicrob Agents Chemother. 2022 May 17;66(5):e0202121. doi: 10.1128/aac.02021-21. Epub 2022 Apr 13.
- Derived from this study: PubMed 33168612Berenstein AJ, Falk N, Moscatelli G, Moroni S, Gonzalez N, Garcia-Bournissen F, Ballering G, Freilij H, Altcheh J. Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults. Antimicrob Agents Chemother. 2021 Jan 20;65(2):e01135-20. doi: 10.1128/AAC.01135-20. Print 2021 Jan 20.
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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 Hospital de Niños R. Gutierrez de Buenos Aires 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. 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?
Results are not available in the source record.
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?
Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients (time frame: Patients treated from 1984 to 2017). 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 NCT04274101, which also lists 2 linked publications.
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 1 Mar 2023.