Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

NCT ID: NCT04274101

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chagas Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Nifurtimox

Patients treated with Nifurtimox from 1984 to 2017

Clinical Manifestations

Intervention Type OTHER

Clinical manifestations in patients treated with Nifurtimox and Benznidazole

Serologic response

Intervention Type DIAGNOSTIC_TEST

Serologic response in patients treated with Nifurtimox and Benznidazole

Direct method

Intervention Type DIAGNOSTIC_TEST

Direct method tests in patients treated with Nifurtimox and Benznidazole

Adverse events

Intervention Type BEHAVIORAL

Adverse events in patients treated with Nifurtimox and Benznidazole

Benznidazole

Patients treated with Benznidazole from 1984 to 2017

Clinical Manifestations

Intervention Type OTHER

Clinical manifestations in patients treated with Nifurtimox and Benznidazole

Serologic response

Intervention Type DIAGNOSTIC_TEST

Serologic response in patients treated with Nifurtimox and Benznidazole

Direct method

Intervention Type DIAGNOSTIC_TEST

Direct method tests in patients treated with Nifurtimox and Benznidazole

Adverse events

Intervention Type BEHAVIORAL

Adverse events in patients treated with Nifurtimox and Benznidazole

Interventions

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Clinical Manifestations

Clinical manifestations in patients treated with Nifurtimox and Benznidazole

Intervention Type OTHER

Serologic response

Serologic response in patients treated with Nifurtimox and Benznidazole

Intervention Type DIAGNOSTIC_TEST

Direct method

Direct method tests in patients treated with Nifurtimox and Benznidazole

Intervention Type DIAGNOSTIC_TEST

Adverse events

Adverse events in patients treated with Nifurtimox and Benznidazole

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- 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.

Exclusion Criteria

\- Patients that abandoned follow-up
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Niños R. Gutierrez de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Dr Jaime Altcheh

PHD MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 35416710 (View on PubMed)

Berenstein 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.

Reference Type DERIVED
PMID: 33168612 (View on PubMed)

Other Identifiers

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Nifurtimox vs. Benznidazole

Identifier Type: -

Identifier Source: org_study_id

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