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Chagas Disease clinical trials

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NCT ID: NCT01547533 Completed - Chagas Disease Clinical Trials

Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease

LACTBENZ
Start date: August 2011
Phase: N/A
Study type: Observational

The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.

NCT ID: NCT01377480 Completed - Chagas Disease Clinical Trials

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

STOP CHAGAS
Start date: July 6, 2011
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01162967 Completed - Chagas Disease Clinical Trials

Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

CHAGASAZOL
Start date: September 2010
Phase: Phase 2
Study type: Interventional

The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.

NCT ID: NCT01006486 Completed - Thrombosis Clinical Trials

Outcomes of an Anticoagulation Clinic in an University Hospital

Start date: November 2009
Phase: Phase 4
Study type: Interventional

A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.

NCT ID: NCT01006473 Completed - Cardiomyopathy Clinical Trials

Exercise Training in Chagas Cardiomyopathy

Start date: March 2007
Phase: Phase 4
Study type: Interventional

The benefits of exercise training in heart failure are well established. Its effects, however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis is that the exercise training may improve functional capacity, quality of life (QoL), and reduce brain natriuretic peptide (BNP) levels in patients with ChC.

NCT ID: NCT00699387 Completed - Chagas Disease Clinical Trials

Population Pharmacokinetics of Benznidazole in Children With Chagas Disease

Start date: April 2007
Phase: N/A
Study type: Interventional

Background: Chagas disease is a parasitic infection caused by the Trypanosome cruzi. The initial phase of the infection happens mainly in children. Up to 10% of infected children die. Survivors often develop chronic infection leading to heart disease and other complications in 30% of patients. These complications often result in death or severe handicaps in early adulthood, depriving societies of individuals in their most productive years. There are 20 million people infected in Latin America. Complications lead to 20,000 deaths every year. Treatment during the acute phase with benznidazole leads to a high cure rate. However, there are very few studies of this drug and virtually none in children, even though benznidazole was developed over 30 years ago. Hypotheses and Specific Aims: We hypothesize that the pharmacokinetics of benznidazole in children is different from adults, and that obtaining information on how it is absorbed, distributed and eliminated in children will allow optimization of treatment of Chagas disease in this population. This will in turn improve the outlook for children by reducing mortality and long term complications. We aim to study the pharmacokinetics of benznidazole in children receiving the drug for treatment of Chagas disease, and to correlate it with treatment effectiveness and incidence of adverse effects. Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of Chagas disease. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.

NCT ID: NCT00511589 Completed - Clinical trials for Protozoan Infections

Chagas Disease Diagnostic - Inconclusive Serology

Start date: n/a
Phase: N/A
Study type: Interventional

T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the chronic phase of infection is performed by indirect serological methods which, nevertheless, leave inconclusive results. One of the direct methods used for T. cruzi identification, blood culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of the disease. A negative result does not eliminate the possibility of infection, but a positive test has high absolute diagnostic value, which enables the indication of antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used as a confirmatory test, particularly when individuals present inconclusive results in conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving blood culture sensitivity in LIT medium by performing PCR in individuals with positive and inconclusive serology for chagasic infection.

NCT ID: NCT00453700 Completed - Chagas Disease Clinical Trials

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

Start date: January 2007
Phase:
Study type: Observational

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. Following acute disease, patients enter into an indeterminate phase which can last 10-20 years. The earliest sign of cardiac involvement usually is electrocardiogram abnormalities. The most common abnormality is right bundle branch block (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block (LBBB). Recent studies have shown that treatment of patients at this stage with antiparasitics may delay the progression of overt cardiomyopathy. At the University of California, Los Angeles, there is a large population of immigrant patients from countries endemic to Chagas disease. The researchers propose that screening patients with conduction abnormalities on electrocardiogram may be a potentially useful method to identify patients with early cardiac manifestations of Chagas disease. The researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on electrocardiogram to determine the incidence of Chagas disease in this patient population.

NCT ID: NCT00123916 Completed - Heart Disease Clinical Trials

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

BENEFIT
Start date: November 2004
Phase: Phase 3
Study type: Interventional

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 with Chronic Chagas' Cardiomyopathy (CCC). The BENEFIT study is being conducted by the Population Health Research Institute (in Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil) together with a Steering Committee, and an independent Safety Monitoring Board.

NCT ID: NCT00023556 Completed - Heart Diseases Clinical Trials

Genetic Architecture of Heart Disease in Rural Brazil

Start date: September 2001
Phase: N/A
Study type: Observational

To examine the genetics of human susceptibility to Chagas' disease, a leading cause of heart disease throughout Latin America.