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Chagas Disease clinical trials

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NCT ID: NCT01842867 Completed - Chagas Disease Clinical Trials

Syndecan-4 as a Biomarker in Patients With Chagas Disease

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to analyze the efficacy of syndecan-4 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.

NCT ID: NCT01842854 Completed - Chagas Disease Clinical Trials

Galectin-3 as a Biomarker in Patients With Chagas Disease

Start date: January 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01787968 Completed - Chagas Disease Clinical Trials

Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

Start date: April 2011
Phase: N/A
Study type: Observational

T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI). TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina. In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. By contrast, we know very little about the congenital transmission of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII. Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. We will estimate the exposure to vectors in the household. In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.

NCT ID: NCT01755403 Completed - Chagas Disease Clinical Trials

Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

CINEBENZ
Start date: December 2012
Phase: Phase 4
Study type: Interventional

o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.

NCT ID: NCT01755377 Completed - Chagas Disease Clinical Trials

New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

BIOMARCHA
Start date: December 2012
Phase: N/A
Study type: Observational

Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.

NCT ID: NCT01744405 Completed - Chagas Disease Clinical Trials

Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease

LACTNFX
Start date: December 2012
Phase: N/A
Study type: Observational

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

NCT ID: NCT01681420 Completed - HIV Clinical Trials

Improving Blood Safety and HIV Testing in Brazil

Start date: August 1, 2012
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01678599 Completed - Chagas Disease Clinical Trials

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

PCR
Start date: April 2011
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01662362 Completed - Chagas Disease Clinical Trials

Abbott ESA Chagas Assay Post-Market Study

ESA
Start date: July 2012
Phase: N/A
Study type: Interventional

The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.

NCT ID: NCT01549236 Completed - Chagas' Disease Clinical Trials

Population Pharmacokinetics Study of Benznidazole in Children With Chagas'Disease

Pop PK Chagas
Start date: May 2011
Phase: Phase 4
Study type: Interventional

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.