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 range18 Years – 50 Years
SexALL
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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).
✕. History of Chagas disease treatment with BZN or NFX or any triazole drug(s) in the last five years.
What they're measuring
1
Sustained Parasitological Clearance by qPCR at End of Follow-Up (36 months)
✕. 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