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Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

ConditionChagas Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLaboratorio Elea Phoenix S.A.

About this trial

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 shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form;

Between ≥18 and ≤60 years of age;

Weight ≥ 50 kg to ≤ 95 kg;

Confirmation of the diagnosis of T. cruzi infection by conventional serology (a minimum of two tests must be reactive);

Disqualifiers

Subject pregnant or intending to become pregnant during treatment and within 30 days of the last dose of study treatment;

Signs or symptoms of the established (moderate- severe) chronic cardiac and/or digestive form of Chagas disease, or any ECG/ echocardiographic findings not included at Inclusion criteria;

History of cardiomyopathy, heart failure, or severe ventricular arrhythmia;

History of digestive surgery potentially related to Chagas Disease or megacolon / mega-esophagus;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Short regimen of benznidazole

    Drug

    Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 2 weeks.

  • Short treatment with benznidazole

    Drug

    Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 4 weeks.

  • Standard treatment with benznidazole

    Drug

    Benznidazole, 300 mg divided into three daily doses (100 mg every 08 hours), orally for 8 weeks

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Short regimen of benznidazole 2 weeksExperimental treatment 1 intervention
Group B: Short regimen of benznidazole 4 weeksExperimental treatment 1 intervention
Group C: Standard treatment with benznidazoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with sustained negativation of parasitemia according to the results of qualitative PCR tests

Sustained parasitological response will be determined by negative serial qualitative PCR results (two negative PCR results from three DNA extractions from a sample) from the end of treatment with the elimination of sustained parasitaemia until the end of 12 months' follow-up from the end of treatment.

Time frame
From the end of treatment, and up to 12 months of follow-up from the end of treatment.

Secondary outcomes

1

Proportion of patients with negative parasitemia at 1, 4, 6 and 8 months follow-up form the end of treatment

Proportion of patients with negative parasitemia at 1, 4, 6 and 8 months follow-up form the end of treatment

Time frame
1, 4, 6 and 8 months from the end of treatment
2

Incidence and severity of adverse events

Incidence and severity of adverse events

Time frame
From the end of treatment, and up to 12 months of follow-up from the end of treatment
3

Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption

Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption

Time frame
From the end of treatment, and up to 12 months of follow-up from the end of treatment.
4

Descriptions of patients adherence to treatment in each study arm.

describing the number of completed treatment in patients vs uncompleted treatment in patients

Time frame
2, 4 and 8 weeks

Other outcomes

1

Incidence and severity of adverse events

Incidence and severity of adverse events

Time frame
From the end of treatment, and up to 12 months of follow-up from the end of treatment.
2

Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption

Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption

Time frame
From the end of treatment, and up to 12 months of follow-up from the end of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laboratorio Elea Phoenix S.A.

Lead sponsor

Drugs for Neglected Diseases

Collaborator

Source ClinicalTrials.gov
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