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Status unknownNCT04274101Updated Mar 1, 2023

Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

An observational study in Chagas Disease, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Status unknown at 1 site in Argentina. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
900
Ages
Up to 18 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Chagas Disease

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

Exclusion Criteria:

  • Patients that abandoned follow-up
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
900 participants (estimated)
Patient registry
No

Groups and cohorts

  • Nifurtimox

    Patients treated with Nifurtimox from 1984 to 2017

    Other: Clinical Manifestations · Diagnostic Test: Serologic response · Diagnostic Test: Direct method · Behavioral: Adverse events

  • Benznidazole

    Patients treated with Benznidazole from 1984 to 2017

    Other: Clinical Manifestations · Diagnostic Test: Serologic response · Diagnostic Test: Direct method · Behavioral: Adverse events

Interventions

  • OtherClinical Manifestations

    Clinical manifestations in patients treated with Nifurtimox and Benznidazole

  • Diagnostic testSerologic response

    Serologic response in patients treated with Nifurtimox and Benznidazole

  • Diagnostic testDirect method

    Direct method tests in patients treated with Nifurtimox and Benznidazole

  • BehavioralAdverse events

    Adverse events in patients treated with Nifurtimox and Benznidazole

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Patients treated from 1984 to 2017

Secondary outcomes

  1. 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)

    Time frame: Patients treated from 1984 to 2017

  2. 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

    Time frame: Patients treated from 1984 to 2017

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Study locations

1 site
  • Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
    Buenos Aires, 1425, Argentina
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References and documents

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 35416710 ↗
  • 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. PubMed 33168612 ↗
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Registry details

Key details

Study ID
NCT04274101
Lead sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Responsible party
Dr Jaime Altcheh (PHD MD, Hospital de Niños R. Gutierrez de Buenos Aires) — Principal investigator
First posted
Feb 18, 2020
Start date
Jun 1, 2018
Primary completion
Aug 1, 2020
Completion
Feb 1, 2025 (estimated)
Last update
Mar 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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