NCT04274101

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

February 14, 2020

Last Update Submit

February 28, 2023

Conditions

Chagas Disease

Outcome Measures

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

    Patients treated from 1984 to 2017

Secondary Outcomes (2)

  • Nifurtimox versus Benznidazole security and tolerance

    Patients treated from 1984 to 2017

  • To compare Chagas disease characteristics associated with treatment

    Patients treated from 1984 to 2017

Study Arms (2)

Nifurtimox

Patients treated with Nifurtimox from 1984 to 2017

Other: Clinical ManifestationsDiagnostic Test: Serologic responseDiagnostic Test: Direct methodBehavioral: Adverse events

Benznidazole

Patients treated with Benznidazole from 1984 to 2017

Other: Clinical ManifestationsDiagnostic Test: Serologic responseDiagnostic Test: Direct methodBehavioral: Adverse events

Interventions

Clinical ManifestationsOTHER

Clinical manifestations in patients treated with Nifurtimox and Benznidazole

BenznidazoleNifurtimox
Serologic responseDIAGNOSTIC_TEST

Serologic response in patients treated with Nifurtimox and Benznidazole

BenznidazoleNifurtimox
Direct methodDIAGNOSTIC_TEST

Direct method tests in patients treated with Nifurtimox and Benznidazole

BenznidazoleNifurtimox
Adverse eventsBEHAVIORAL

Adverse events in patients treated with Nifurtimox and Benznidazole

BenznidazoleNifurtimox

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- Patients that abandoned follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Buenos Aires, 1425, Argentina

Location

Related Publications (2)

  • 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.

    PMID: 35416710DERIVED

  • 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.

    PMID: 33168612DERIVED

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD MD

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 18, 2020

Study Start

June 1, 2018

Primary Completion

August 1, 2020

Study Completion

February 1, 2025

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

AR(1)