Actively Recruiting

Phase 3
Age: 18Years - 60Years
All Genders
ID04897516

Phase III Randomized Multicenter Study Comparing Shorter Benznidazole Regimens to Standard Treatment in Adults With Chronic Chagas Disease

Led by Laboratorio Elea Phoenix S.A. · Updated on 2023-11-30

300

Participants Needed

6

Research Sites

26 weeks

Total Duration

On this page

Sponsors

L

Laboratorio Elea Phoenix S.A.

Lead Sponsor

D

Drugs for Neglected Diseases

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chagas disease is a parasitic infection caused by Trypanosoma cruzi, affecting millions worldwide, especially in Latin America. Current treatments with benznidazole and nifurtimox have significant side effects and long durations, making it difficult for many adults to complete therapy. This study evaluates whether shorter treatment plans of 14 and 28 days with benznidazole are as effective as the standard 60-day course, aiming to improve safety and treatment completion rates in adults with chronic Chagas disease in its indeterminate or mild cardiac forms. Participants will be randomly assigned to one of three groups receiving benznidazole at 300 mg daily divided into three doses: a 2-week regimen, a 4-week regimen, or the standard 8-week regimen. The study is a Phase III, multicenter, randomized trial comparing the efficacy and safety of these three treatment durations. The two shorter regimens are experimental, while the 8-week treatment serves as the active comparator. During the study, participants will have periodic blood tests using qualitative PCR to monitor parasite levels from the end of treatment up to 12 months afterward. Safety will be assessed by tracking adverse events and treatment interruptions. Researchers will also observe patient adherence to treatment in each group. Overall participation includes treatment and follow-up visits over at least 12 months to evaluate sustained parasite clearance and safety outcomes.

CONDITIONS

Brief Title

Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Age between 18 and 60 years
  • Weight between 50 kg and 95 kg
  • Confirmed diagnosis of Trypanosoma cruzi infection by at least two reactive serology tests
  • Positive qualitative PCR test for T. cruzi
  • For women of childbearing potential: negative pregnancy test, not breastfeeding, and use of effective contraception during treatment and 30 days after
  • Ability to comply with study exams and visits
  • Having a permanent address
  • Heart rate between 50-100 bpm or isolated sinus bradycardia (41-59 bpm); QRS ≤120 msec; QTc 350-450 msec, or non-severe chagasic cardiomyopathy findings
  • Normal or minimal changes on echocardiogram without severe cardiac dysfunction
  • No signs or symptoms of moderate to severe chronic cardiac or digestive Chagas disease
  • No prior mental disorders or suicidal tendencies
  • No acute or chronic illnesses interfering with study evaluation
  • No contraindication to benznidazole
  • No history of allergy or serious reactions to nitroimidazole compounds
  • No prior antiparasitic treatment for T. cruzi
  • No history of drug abuse or alcoholism
  • Able to take oral medication
Not Eligible

You will not qualify if you...

  • Pregnant or intending to become pregnant during or within 30 days after treatment
  • Signs or symptoms of moderate to severe chronic cardiac or digestive Chagas disease
  • ECG or echocardiographic abnormalities not allowed by inclusion criteria
  • History of cardiomyopathy, heart failure, or severe ventricular arrhythmia
  • History of digestive surgery related to Chagas disease or megacolon/mega-esophagus
  • Acute or chronic diseases interfering with safety or efficacy evaluation
  • Abnormal lab test values beyond allowable limits
  • Conditions preventing oral medication intake
  • Known hypersensitivity to nitroimidazole compounds
  • History of allergy, asthma, intolerance, or photosensitivity
  • Use of interfering medications like allopurinol or antimicrobials
  • Scheduled surgery interfering with trial
  • Inability to attend visits or comply with study procedures
  • Prior participation in T. cruzi treatment trials
  • Participation in other trials within 3 months
  • Serious medical or psychiatric illness increasing risk or affecting results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2, 4, or 8 weeks depending on assigned treatment group

Participants receive benznidazole treatment in one of three regimens: 2 weeks, 4 weeks, or the standard 8 weeks, to reduce and eliminate the Trypanosoma cruzi parasite.

Visits occur during the treatment period as required for medication administration and monitoring

Follow-up

Duration - Up to 12 months after treatment

Participants are monitored for up to 12 months after treatment to assess parasite clearance, safety, and adherence to the treatment.

Visits at 1, 4, 6, 8 months and additional visits up to 12 months for safety and efficacy assessments

Trial Site Locations

Total: 6 locations

1

Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben"

Buenos Aires, Argentina, C1097

Not Yet Recruiting

2

Fundación Huésped

Buenos Aires, Argentina, C1202ABB

Actively Recruiting

3

Hospital Francisco Javier Muñiz

Buenos Aires, Argentina, C1282A

Actively Recruiting

4

Hospital Donación Francisco Santojanni

Buenos Aires, Argentina, C1408INH

Not Yet Recruiting

5

Instituto de Cardiología de Corrientes "Juana Francisca Cabral"

Corrientes, Argentina, W3400

Actively Recruiting

6

Centro de Chagas y Patología Regional, Hospital Independencia

Santiago del Estero, Argentina, G4200

Actively Recruiting

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Research Team

C

Carola Lombas, MD

T

Tayná Marques, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial.

Tayná Marques, Colin Forsyth, Fabiana Barreira...

https://pubmed.ncbi.nlm.nih.gov/41027700