New Therapies and Biomarkers for Chagas Infection (NCT03981523) | Clinical Trial Compass
CompletedPhase 2
New Therapies and Biomarkers for Chagas Infection
Bolivia450 participantsStarted 2019-12-18
Plain-language summary
Chagas disease (CD) is an endemic zoonotic disease with a significant global impact. Current approved treatments for CD (benznidazole (BZN) and nifurtimox (NFX)) were developed in the 1970s with regimens and dosing intervals derived from decades-old patient series and with very limited direct comparisons. Treatment recommendations vary significantly from country to country and the comparative evidence-base with the current treatment regimens is limited.
The reported efficacy of both drugs in patients with T. cruzi infection is variable and depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi strain or genotype. Due to a therapeutic failure of at least 20% after 12 months in chronic patients and the high rate of adverse events, together with the recent data that suggest that we may be overdosing patients, we propose to test new dosing regimens of these two old compounds.
Hypotheses:
* Lowering the frequency of drug dosing of BZN and NFX, the plasma drug levels of the drugs within the therapeutic range will be maintained.
* The duration of treatment with BZN or NFX may be related to the effectiveness of these drugs.
* Blood levels of the proposed biomarkers will significantly diminish or became negative after a relatively short interval after treatment.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults, 18-50 years.
. Weight: 88-198 pounds (40-90 Kg).
. Individuals diagnosed as being infected with T. cruzi by conventional serology (two positive tests with different antigens) with at least one positive qualitative RT-PCR assay out of three during the screening.
. Patient classified as being in the indeterminate form (without clinical manifestations) or early cardiac form (Kushnir 1) of chronic Chagas disease.
. Signed informed consent form (ICF).
Exclusion criteria
. Clinical signs of dilated cardiomyopathy (dyspnea, legs' edema, syncope, pulmonary crackles). Patients with an EKG showing the following characteristics: sinus tachycardia or atrial fibrillation, ventricular arrhythmias, left atrial enlargement, left bundle-branch block (LBBB) accompanied by right axis deviation (RAD), and/or patients with Calculation of Fridericia's corrected QT interval (QTcF) \> 450ms, a formula for calculating the QT interval on an electrocardiogram (ECG).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained Parasitological Clearance by qPCR at End of Follow-Up (36 months)
. History of Chagas disease treatment with BZN or NFX or any triazole drug(s) in the last five years.
. Clinical signs and/or symptoms of digestive form of Chagas disease, which is characterized by the presence of two or more of the following criteria \*:
. Excessive exertion in at least 25% of bowel movements
. Hard stools in at least 25% of stools (type 1-2 of Bristol)
. Feeling of incomplete evacuation in at least 25% of bowel movements
. Feeling of obstruction or anorectal block in at least 25% of bowel movements
. Manual maneuvers to facilitate defecation in at least 25% of bowel movements