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Compares treatment options for Chagas Disease
Official title Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
ClinicalTrials.gov ID: NCT04897516
What this study is testing
What is Short regimen of benznidazole?
Short regimen of benznidazole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chagas disease.
Also referred to as Benznidazole 2 weeks.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- (people must meet ALL the inclusion requirements listed below to enter the study):
- 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);
You likely can't join if
- (The presence of any of the items below will exclude people from inclusion in the study):
- 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...
- History of cardiomyopathy, heart failure, or severe ventricular arrhythmia;
- History of digestive surgery potentially related to Chagas Disease or megacolon / mega-esophagus;
- Acute or chronic disease that, in the Investigator's discretion, may interfere with the evaluation of the how well it works or safety of the...
See the full eligibility criteria
- (people must meet ALL the inclusion requirements listed below to enter the study):
- 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);
- Serial qualitative PCR (one blood sample divided in three DNA extractions, at least one of which must be positive);
- 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 during study treatment and until 30...
- Ability to comply with all exams and specific protocol visits;
- Having a permanent address;
- ECG criteria: (Heart rate: 50 -100 bpm or isolate sinus bradycardia from 41 to 59 beats/min; QRS ≤120 msec, and QTc ≥ 350 msec and ≤ 450 msec) at screening) or following findings belonging to non-severe chagasic...
- Normal or minimal structural changes in echocardiogram (left ventricular diastolic diameter (LVDD) \<= 55 mm, diastolic dysfunction, absence of Microaneurysm or tip aneurysm, absence of hypo or generalized akinesia...
- Not presenting signs or symptoms of moderate- severe chronic cardiac and/or digestive forms of Chagas disease (criteria detailed in Study Manual and specific SOP);
- No prior history of mental disorders or suicidal tendencies;
- Not suffering from known acute or chronic illnesses at the moment of selection for the study that, in the Investigator's discretion, may interfere with the evaluation of the how well it works or safety of the...
- Not having received a formal indication not to take BZN (contraindication, according to the Summary of Product Characteristics - SmPC);
- No prior history of hypersensitivity, allergy, or serious adverse reactions to any of the nitroimidazole compounds (including BNZ) and/or its components/excipients;
- Have not previously undergone antiparasitic treatment for T. cruzi infection;
- No prior history of drug abuse or alcoholism;
- Not suffering from any disease or condition that prevents people from consuming oral medication.
- (The presence of any of the items below will exclude people from inclusion in the study):
- 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;
- Acute or chronic disease that, in the Investigator's discretion, may interfere with the evaluation of the how well it works or safety of the investigational product (such as acute infection, history of immunosuppressive...
- Laboratory test values that are considered clinically significant or outside the allowable values, per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1;
- Disease or clinical condition that prevents people from consuming oral medication;
- people with a contraindication (known hypersensitivity) to any of the nitroimidazole compounds, e.g. metronidazole;
- people with a history of allergy (serious or not), allergic rash, asthma, intolerance, sensitivity or photosensitivity;
- 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 T. cruzi infection;
- Simultaneous participation in another trial or within 3 months prior to screening for this trial (in accordance with national regulations).
- people suffering from a serious medical or psychiatric illness that increases the risk associated with study participation or that interferes with the interpretation of study results should not be included.
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
- Corrientes, Argentina
- Santiago del Estero, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; Corrientes, Argentina; Santiago del Estero, Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.