Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients

NCT06339710 | Withdrawn Phase 3

• 1 other identifier: U1111-1288-5508
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects. The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events.

Conditions

Chronic Chagas Disease

Keywords

Chagas disease; Short treatment; Benznidazole

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment.

  The treatment efficacy of each treatment arm is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 24 months after starting treatment

  during the 24-month follow-up

Secondary Outcomes (2)

• Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period

  during treatment period (up to 8 weeks)

• Proportion of participants with positive PCR at different time points

  At the different time points: 1, 4, 6, 8, 12, 18 and 24 months after the end of treatment

Other Outcomes (3)

• Incidence and severity of clinically relevant events attributed to Chagas disease

  during the 24-month follow-up

• To measure the quality of life (QoL) of participants

  during the 24-month follow-up

• To measure the quality of life (QoL) of participants

  during the 24-month follow-up

Study Arms (3)

Short treatment 1

EXPERIMENTAL

benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or

Drug: benznidazole 300 mg daily 8 weeks

Short Treatment 2

EXPERIMENTAL

benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks

Drug: benznidazole 300 mg daily 8 weeks

Standard treatment

ACTIVE COMPARATOR

benznidazole 300 mg daily for 8 weeks

Drug: benznidazole 300 mg daily 8 weeks

Interventions

benznidazole 300 mg daily 8 weeks DRUG

672 participants will be randomly assigned to receive the standard-dose of benznidazole (300 mg daily for 8 weeks) or the short experimental regimens (benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks)

Also known as: benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks, benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks

Short Treatment 2; Short treatment 1; Standard treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• CD diagnosis through the positivity of two serological tests that use different antigens (recombinant and native antigens, according to World Health Organization (WHO) recommendations) (28).
• Informed consent form read and signed by the participant.
• Weight ≥ 50 kg to ≤ 95 kg.

You may not qualify if:

• o Currently pregnant, breastfeeding or expressing gestational desire for the next 2 months.
• Previously received treatment with Benznidazole (BZN) or NIfurtimox (NFX) - (either completely or incompletely);
• Any concomitant use or documented history of using allopurinol or antifungals (ketoconazole, itraconazole and posaconazole);
• History of hypersensitivity, allergic or serious adverse event (SAE) to any "nitroimidazole", and/or its components;
• Acute or chronic health problems that, in the informed opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the drug. Examples are acute infections, Human Immunodeficiency Virus (HIV) infections, liver disease with liver failure and kidney disease requiring support treatment;
• Signs and/or symptoms of severe cardiac form of CD ;
• History of cardiomyopathy, heart failure or severe ventricular arrhythmia of any etiology;
• Alcoholic participants or those with a history of alcohol abuse (considered as intake of \>4 drinks on any single day AND \>14 drinks per week for men and \>3 drinks on any single day AND \>7 drinks per week for women);
• Have basic laboratory parameters outside the normal range or parameters that are considered clinically relevant by the physician responsible for the participant;
• Participation in another clinical trial over the past 12 months.

Sponsors & Collaborators

• Evandro Chagas Institute of Clinical Research: lead
• Andrea Silvestre de Sousa: collaborator

Study Sites (2)

Israel Molina

Minas Gerais, Belo Horizonte, Brazil

Location

Monique Gurgel de Oliveira

Rio de Janeiro, Rio de Janeiro, 24350211, Brazil

Location

MeSH Terms

Conditions

Chagas Disease

Interventions

benzonidazole

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: April 1, 2024
• Study Start: January 30, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)