Clinical trial NCT04274101: Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment
Official title: Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment, Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chagas Disease
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 900
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients
timeFrame: Patients treated from 1984 to 2017
Secondary outcomes:
measure: Nifurtimox versus Benznidazole security and tolerance
timeFrame: Patients treated from 1984 to 2017
measure: To compare Chagas disease characteristics associated with treatment
timeFrame: Patients treated from 1984 to 2017
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Study officials:
References:
citation: 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.
citation: 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.