Clinical Trials for Chagas Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Chagas Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 4
• Active, not recruiting: 2
• Completed: 30
• Other: 14

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04897516 — Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

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 o…

NCT05519046 — Cardiac Contractility Modulation in Chagas Heart Disease

Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent…

NCT06632600 — A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.

This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.

NCT07304349 — Prospective Evaluation of Rapid Diagnostic Tests for Trypanosoma Cruzi Infection

Chagas disease (CD) is the most significant endemic zoonosis in Argentina. Two-thirds of affected individuals live in urban areas but only 10% globally are aware of their infection. Diagnosing Chronic Chagas (CCD) requires at least two serological tests, often limited to reference laboratories, creating logistical and economic challenges that delay timely diagnosis and treatment. Although prima…

Active, Not Recruiting

NCT04024163 — Prospective Study of Benznidazole for Chagas’ Disease Children With Chronic Indeterminate Chagas Disease

This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.

NCT04984265 — SBRT in Chagas Disease Ventricular Tachycardia

This is an observational study of 10 Chagas Disease patients with Ventricular Tachycardia that have failed prior catheter ablation or have this procedure contraindicated due to clinical status. Those patients will underwent to Stereotactic Body Radiation Therapy (SBRT) targeting the area of the heart of the VT circuits. Radioablation target will be defined based on prior ablation electroanatomi…

Not Yet Recruiting

NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother’s and Baby’s Health

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.

Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later c…

Completed Trials

NCT00123916 — BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas’ Disease

Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient’s body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients…

NCT00453700 — Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram

Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease. Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a high associated morbidity. Foll…

NCT02327052 — Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Chagas Disease

One of the most challenging issues of chronic Chagas disease is to provide earlier detection of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new imaging modality with useful applications in several cardiac diseases, has been validated for subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the investigators hypothesize that the …

NCT01842854 — Galectin-3 as a Biomarker in Patients With Chagas Disease

The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

NCT01678599 — Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease

The purpose of this study is to estimate the gain in sensitivity of several multiple-sample strategies of PCR samples with respect to the current standard (single sample of 10 ml) to detect Chagas chronic stage at baseline and to identify the optimal sampling strategy based on the sensitivity, cost,the completeness of sampling and the acceptability for study patients.

NCT01549236 — Population Pharmacokinetics Study of Benznidazole in Children With Chagas’Disease

The purpose of this study is to describe the population pharmacokinetics parameters of benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.

NCT01377480 — A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)

This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.

NCT01681420 — Improving Blood Safety and HIV Testing in Brazil

Conduct a randomized controlled trial (RCT) to test the hypothesis that offering client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the risk of HIV contamination in the blood supply and also increase appropriate referrals to preventive and care services to persons in need in São Paulo, Brazil.

NCT03892213 — Pharmacokinetic Drug-Drug Interaction Study

The purpose of this study is to determine whether benznidazole and E1224 should be administered concomitantly in patients with Chagas Disease as not enough data are available. This study aims to assess cross interactions of these two compounds.

NCT04090489 — Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children

Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. The acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. The chronic phase usual…

NCT02517632 — Physical Exercise Program in Chronic Chagas Heart Disease

The aim of this investigation is to evaluate the impact of exercise in a cardiac rehabilitation program on functional capacity, clinical markers, quality of life and biomarkers in patients with chronic chagasic cardiomyopathy.

NCT02544139 — Specificity Study of Diagnostic for Chagas Disease

This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.

The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole blood samples. Reactive assay results are presumptive evi…

NCT02154269 — Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.

NCT02625974 — A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas’ Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi

Researchers are looking for a better way to treat children who have an infectious disease caused by the parasite Trypanosoma cruzi (Chagas’ disease).

Chagas’disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas’ disease is left untreated, it can later cause serious heart and digestive …

NCT03191162 — Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.

A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after startin…

NCT03189056 — Lower Urinary Tract Dysfunction in Chronic Chagas’ Disease : Clinical and Urodynamic Presentation

Chagas disease is one of the most neglected vector-borne infectious disease worldwide. The first decades following the discovery of the pathology drove an international research enthusiasm, mainly concentrated on understanding the typical cardiac and digestive forms. Recently, research have been focused on vector control, which has been a huge success, at the price of neglecting the patients wh…

NCT03587766 — Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease

This study focuses on the evaluation of low doses (600 and 1200 mg) and short treatment duration (at 3, 7 and 10 days) of fexinidazole (Fexi) to determine the minimal efficacious and safe dose for the treatment of adult patients with chronic indeterminate Chagas Disease (CD).

NCT03350295 — Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg

Study to assess the relative Bioavailability To assess the relative bioavailability of three formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles To assess the pharmacokinetics (PK) of nifurtimox To investigate the safety and tolerability of nifurtimox.

NCT03524768 — Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.

The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.

NCT04239144 — Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease

Ventricular tachycardia (VT) is the main cause of sudden death in patients with structural heart diseases. The use of ICD (implantable cardio-defibrillator) could prevent sudden death, however, the occurrence of repetitive shock decreases significantly the quality of life and could increase the mortality rate. Chagas disease in our environment is the most common heart disease and often associat…

NCT03708133 — Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation

The primary objective of the current study is to investigate the bioequivalence of a newly developed 120 mg nifurtimox tablet formulation (Test treatment) compared with the 120 mg nifurtimox tablet currently used in the Bayer pediatric clinical development program (Reference treatment). The new tablet formulation assessed in this study is intended to replace the 120 mg nifurtimox tablet formula…

NCT03784391 — Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina

The researchers in this trial want to analyze prerecorded patient data which provide information on benefits of the drug nifurtimox in patients with a sudden (acute) and long lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans by a bug. They also want to learn how often organs, especially the heart, are affected by the illness in treated and untreated c…

NCT03672487 — Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age

The investigators are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short 30-day treatment with BZN 150mg/day (30d/150mg) vs. a 60-day treatment with BZN 300 mg/day (60d/300mg). The investigators will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at six month…

NCT03334838 — Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas’ Patients - Dietary Habits Study

This study evaluated the effect of food on the absorption of the drug as well as safety and tolerability in adults suffering from chronic Chagas’ disease In addition pharmacokinetics of the drug following 120 and 240 mg single doses will be assessed

NCT04023227 — Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC

The purpose of this study was to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of cardiovascular (CV) events (i.e. CV death or the occurrence of first HF hospitalization) and causing a greater reduction in n terminal prohormone of brain natriuretic peptide …

NCT03981523 — New Therapies and Biomarkers for Chagas Infection

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 e…

NCT06806722 — Cardiac Mechanics by Speckle Tracking as a Prognostic Predictor in Patients With Chagas Cardiomyopathy

This study aims to evaluate the prognostic value of myocardial mechanics parameters, including global longitudinal strain (GLS) and mechanical dispersion (MD), assessed through speckle tracking echocardiography, in patients with Chagas cardiomyopathy (CCM). The study is divided into two arms: a cross-sectional arm and a longitudinal arm. The cross-sectional arm compares echocardiographic parame…

NCT05868005 — Delivering a Multi-disease Screening Tool to Migrant Populations

Migrants’ overall health status may be improved by increasing the detection of certain infectious diseases and other conditions for which effective care is available. This can be achieved through a systematic screening of these conditions using innovative and digital solutions implemented in routine health care.

This study aims to evaluate the implementation of a screening programme for migran…

NCT07033325 — University-Based Chagas Testing in Salta Province, Argentina

The goal of this observational study is to improve access to diagnosis and treatment for chronic Trypanosoma cruzi infection among university students of all ages and genders at the National University of Salta (UNSa), Argentina. The main questions it aims to answer are:

• What is the seroprevalence and geographic distribution of T. cruzi infection in UNSa students?
• Can voluntary point-of-ca…

NCT07024589 — First-in-Human Trial of Oral AN2-502998

First-in-Human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

Other (Terminated)

NCT00349271 — Cell Therapy in Chagas Cardiomyopathy

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Other (Unknown)

NCT01650792 — Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS)

The main purpose of the study is to determine noninvasive markers of brain involvement in Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on transcranial Doppler monitorization, the investigators aim to determine the efficacy and safety of aspirin in preventing microembolization in patients with no previous history of stroke. Specific aims are listed bello…

NCT01722942 — Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death

The primary objective is to compare the efficacy of the treatment using implantable cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in the primary prevention of all-cause mortality in high-risk patients with Chagas cardiomyopathy and non-sustained ventricular tachycardia (NSVT).

NCT02542020 — Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis

Human immunodeficiency virus (HIV) infection is a major global health issue with up to 40 million people infected worldwide. Due to highly active antiretroviral therapy, mortality related to acquired immunodeficiency syndrome (AIDS) has been reducing in the last decades. However, liver disease remains as an important cause of severe complications and death.

Hepatic fibrosis progression is the …

NCT02369978 — CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)

This randomized, blind, parallel-group trial will evaluate the efficacy and safety of Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite Trypanosoma cruzi.

The investigators will test whether NFX is an effective trypanocidal agent (by comparison with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related and safety outcom…

NCT03378661 — BENDITA BEnznidazole New Doses Improved Treatment and Associations

Recent scientific advances have provided further impetus to develop new therapeutic approaches for Chagas Disease (CD) using different doses and duration of BZN, as well as combinations directed at multiple therapeutic targets to improve treatment response and tolerability and reduce the potential for development of resistance.

This project focuses on the proof-of-concept evaluation of improve…

NCT03193749 — A Trial Testing Amiodarone in Chagas Cardiomiopathy

Purpose:

The ATTACH trial, as currently designed, will primarily test whether a treatment with Amiodarone for at least 6 months has a trypanocidal effect among individuals with mild-to-moderate Chronic Chagas Cardiomyopathy. A secondary goal will be to confirm, in this population, a clinical benefit from this treatment (in terms of reducing mortality or cardiac arrhythmic events), and to explo…

NCT04274101 — Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission.

Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They …

NCT03704181 — Colchicine for Patients With Chagas´ Disease( B1 Stage)

This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease.

Forty patients will receive colchicine while twenty patients will receive placebo

NCT04084379 — Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases

Chagas disease and syphilis are considered a mayor public health problem worldwide. Both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. The current diagnostic methods for these diseases are based on serology follow-up until 8 to 10 months from birth, which considering the population …

NCT04853758 — Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF.

Chagas disease is considered by the World Health Organization (WHO) as one of the most neglected tropical diseases in the world, having relevance in many Latin America countries. In addition, it already affects North America, Europe, Asia and Oceania. Some studies suggest that chagasic heart failure has a worse prognosis, with up to 50% shorter survival than other etiologies. The PARADIGM-HF (P…

NCT04984616 — Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease

Chagas Disease, caused by the parasite Trypanosoma cruzi afflicts 7 million people in Latin America, and due to migration, abroad. The diagnosis lies in clinical suspicion and serologic detection of antibodies. Cardiac evaluation is essential because complications, including heart failure and arrhythmias, are the main causes of disability and death. Heart involvement is explained by a parasite-…

Other (Withdrawn)

NCT06339710 — Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients

Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects.

The …