New Scheme for Treatment With Benznidazole

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that a shorter treatment regimen of 14 days will be non-inferior to the standard 60-day treatment while improving the safety profile.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorio Elea Phoenix S.A.
• Collaborator: Drugs for Neglected Diseases initiative
• Treatments: Benzonidazole

Criteria

Screening Criteria:

• Signed informed consent form.

• Between ≥18 and ≤60 years of age.

• Diagnosis of T. cruzi infection by conventional serology (a minimum of two positive tests).

• Ability to comply with all exams and specific protocol visits. Having a permanent address.

• Not presenting signs or symptoms of chronic cardiac and/or digestive forms of Chagas disease, defined according to national guidelines.

• No prior history of mental disorders or suicidal tendencies.

• Not suffering from acute or chronic illnesses that, in the Investigator's discretion, may interfere with the evaluation of the efficacy or safety of the investigational product (such as acute infections, a history of HIV infection, or liver or kidney diseases that have required treatment).

• Not having received a formal indication not to take BZN (contraindication, according to the Summary of Product Characteristics - SmPC). Contraindications to BZN basically include hypersensitivity to the active substance and its excipients. According to the SmPC for BZN, subjects will be advised not to drink alcoholic beverages during treatment.

• No prior history of hypersensitivity, allergy, or serious adverse reactions to any of the nitroimidazole compounds and/or its components.

• Have not previously undergone antiparasitic treatment for Chagas disease.

• No prior history of drug abuse or alcoholism.

• Not suffering from any disease that prevents subjects from consuming oral medication.

Inclusion Criteria:

After the screening period, subjects must meet ALL the inclusion criteria detailed below for recruitment:

Confirmation of the diagnosis of T. cruzi infection by:

Serial qualitative PCR (three samples collected on the same day, at least one of which must be positive)

AND

Conventional serology (a minimum of two tests must be reactive).

• Women of childbearing potential must have a negative pregnancy result at the time of inclusion, must not be breast-feeding, and must use a highly effective method of contraception until completion of the trial.

• Normal ECG (Heart rate: 50 -100 bpm; interval duration: PR ≤ 200 msec, QRS ≤120 msec, and QTc ≥ 350 msec and ≤ 450 msec) at screening.

• Normal echocardiogram (left ventricular diastolic diameter (LVDD) <= 55 mm, absence of Microaneurysm or tip aneurysm, Hypo or generalized akinesia, Systolic dysfunction (low fractional shortening and ejection fraction), and/or Mural thrombus).

• Normal chest X-ray (Cardiac silhouette with index <0.5).

Exclusion Criteria:

The presence of any of the items below will exclude subjects from inclusion in the study:

• Patient pregnant or intending to become pregnant during treatment and within 30 days of the last dose of study treatment.

• Signs or symptoms of the chronic cardiac and/or digestive form of Chagas disease, defined according to national guidelines.

• History of cardiomyopathy, heart failure, or ventricular arrhythmia.

• History of digestive surgery or mega syndromes.

• Acute or chronic disease that, in the Investigator's discretion, may interfere with the evaluation of the efficacy or safety of the investigational product (such as acute infection, history of HIV infection, or liver or kidney disease that has required treatment).

• Laboratory test values that are considered clinically significant or outside the allowable values, per CTCAE version 5.0 grade 1.

• Disease that prevents subjects from consuming oral medication.

• Subjects with a contraindication (known hypersensitivity) to any of the nitroimidazole compounds, e.g. metronidazole.

• Subjects with a history of allergy (serious or not), allergic rash, asthma, intolerance, sensitivity or photosensitivity to any drug.

• Concomitant use and/or consumption of allopurinol, antimicrobial and antiparasitic agents, herbal medicines, dietary supplements and energy drinks.

• Scheduled surgery that may interfere with the conduct of the trial and/or with the treatment evaluation.

• Inability to attend study visits, comply with treatment, and cooperate with study procedures.

• Previous participation in a trial for the evaluation of the treatment of Chagas disease.

• Simultaneous participation in another trial or within 3 months prior to screening for this trial (in accordance with national regulations).

• Serious medical or psychiatric illness that increases the risk associated with study participation or that interferes with the interpretation of study results