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Chagas Disease clinical trials

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NCT ID: NCT04090489 Completed - Chagas Disease Clinical Trials

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

Start date: January 22, 2015
Phase:
Study type: Observational

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 usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. Progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic Chagas heart disease. Objective: To evaluate cardiac involvement in children after pharmacological treatment for Chagas disease. Methods: Open exploratory study, blind for cardiological evaluation. Population: children treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were included as a control group for final cardiological evaluation. Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter. Electrocardiogram (ECG) was performed at diagnosis and every year after treatment. In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.

NCT ID: NCT03892213 Completed - Chagas Disease Clinical Trials

Pharmacokinetic Drug-Drug Interaction Study

Start date: October 2014
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03784391 Completed - Chagas' Disease Clinical Trials

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

Start date: December 14, 2018
Phase:
Study type: Observational

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 chronic Chaga's patients. In order to find this out medical records of adult and pediatric patients in Argentina will be analyzed.

NCT ID: NCT03587766 Completed - Clinical trials for Chagas' Disease (Chronic) Nos

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

FEXI12
Start date: November 13, 2017
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT03524768 Completed - Clinical trials for Chagas Cardiomyopathy

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

Start date: August 20, 2018
Phase:
Study type: Observational

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.

NCT ID: NCT03350295 Completed - Chagas Disease Clinical Trials

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

Start date: June 14, 2018
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03334838 Completed - Chagas' Disease Clinical Trials

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

Start date: June 10, 2019
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT03191162 Completed - Chagas Disease Clinical Trials

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

MULTIBENZ
Start date: April 21, 2017
Phase: Phase 2
Study type: Interventional

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 starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.

NCT ID: NCT03189056 Completed - Clinical trials for Chagas' Disease (Chronic) With Other Organ Involvement

Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation

Start date: July 14, 2017
Phase:
Study type: Observational

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 who already presented fixed and severe organic lesions due the chronic phase of the illness. This study focus on a rarely studied aspect of this pathology: the involvement of the lower urinary tract and it's symptomatology in adults suffering from Chagas chronic disease. Various studies have assessed the involvement of the lower urinary tract in chronic Chagas disease, the vast majority of them being on the animal model or very ancient human studies mainly on cadaveric specimen, the first of them being the primary description of Koeberle in 1963. Human symptomatology deriving from bladder, ureteral and urethral chronic chagasic lesions are yet widely unknown, and only a few Brazilian and Mexican studies have intended to describe the clinical and urodynamic presentation of these patients. The aim of this study is to assess the prevalence of urinary disorders in chronic chagasic patients and to describe their symptoms, through a complete clinical, ultrasonographic and urodynamic description.

NCT ID: NCT02646943 Completed - Chagas Disease Clinical Trials

Longitudinal Study of Patients With Chronic Chagas Cardiomyopathy in Brazil (SaMi_Trop Project)

SaMi-Trop
Start date: July 2013
Phase: N/A
Study type: Observational

BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world, with 8-10 million infected people and only one marginally effective therapeutic. The lack of good biomarkers for active infection or clinical end-points poses a problem for assessing the performance of new drugs or therapeutic interventions. Among the biomarkers, several studies showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left ventricular systolic and diastolic dysfunction. OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma cruzi infection with the goal of finding an array of biomarkers that correlate with parasite persistence and Chagas cardiac disease status that can be used to infer risk of disease progression and death as well used as markers of cure (parasite eradication) or clinical efficacy (stabilize or reverse cardiac damage) of novel drugs METHOD: The investigators established a prospective cohort of 1,959 patients with chronic Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline and 24 months) . The evaluation included collection of socio-demographic information, social determinants of health, health-related behaviours, comorbidities, medicines in use, history of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life, blood sample collection and ECG.